Combination treatment systems

ABSTRACT

Controllers for dry eye treatment apparatus and methods are described herein which generally comprise a patch or strip affixed to the skin of the upper and/or lower eyelids to deliver heat to the one or more meibomian glands contained within the underlying skin. The treatment strip or strips include one or more strips configured to adhere to an underlying region of skin in proximity to one or both eyes of a subject such that the one or more strips allow for the subject to blink naturally without restriction from the one or more patches. A controller is in communication with the one or more strips and is programmable to monitor a temperature of the one or more strips to provide a treatment therapy above a threshold temperature. Additionally forceps for mechanically expressing the Meibomian glands may be included with the strips and/or controller.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority to U.S. Prov. PatentApplication No. 62/266,483 filed Dec. 11, 2015 and is also acontinuation-in-part of U.S. patent application Ser. No. 14/967,116filed Dec. 11, 2015, which is a continuation-in-part of U.S. patentapplication Ser. No. 13/645,985 filed Oct. 5, 2012 (now U.S. Pat. No.9,510,972), which is a continuation-in-part of U.S. patent applicationSer. No. 13/343,407 filed Jan. 4, 2012, each of which is incorporatedherein by reference in its entirety,

FIELD OF THE INVENTION

The present invention relates to methods and apparatus for treatment ofdry eye syndrome and other related conditions. More particularly, thepresent invention relates to methods and apparatus having a programmablecontroller for the treatment of dry eye syndrome using adhesive stripswhich are specifically contoured or shaped to adhere to selected,regions around a patient's eyes or peri-orbital region. Additionally,the present invention relates to various forceps embodiments used formeibomian gland expression and the treatment of dry eye syndrome,evaporative dry eye, and meibomian gland disease.

BACKGROUND OF THE INVENTION

Tears are a complex mixture of water, lipids, mucus, proteins andelectrolytes and this mixture helps to maintain a smooth, lubricious,and optically clear optical surface and also helps to protect the eyesfrom infection. The tear film has three basic layers: oil, water, andmucus and problems or disturbances in any of these layers can causeocular surface problems including dry eye symptoms.

The outermost layer of the tear film is typically comprised of an oillayer containing fatty acids and lipids (meibum), which are producedprimarily by sebaceous glands called the meibomian glands located alongthe eyelid margin. The oil layer smoothes the tear surface and retardsevaporation of the aqueous or watery middle layer. However, if themeibomian glands fail to produce enough oil, produce suboptimal fattyacid mixtures, or if the glands become obstructed or clogged, the waterylayer typically evaporates too quickly causing dry eyes. A blockage orinflammation of the meibomian glands can, among many things, lead toenlarged glands or infections, inspissated secretions, styes, chalazia,hordeolum, or preseptal cellulitis. Dry eyes are thus common in peoplewhose meibomian glands are obstructed or functioning improperly. Theaforementioned are some examples of meibomian gland dysfunction which isalso sometimes referred to as evaporative dry eye.

The middle watery layer of tears is composed primarily of an aqueoussolution, which is produced by the lacrimal glands and accessory glands(tear glands). The middle layer cleanses the eyes and washes awayforeign particles or irritants, maintains a clear optical medium, andkeeps the ocular surface moist. The innermost layer of the tear film iscomposed primarily of mucus, which helps to spread the tears evenly overthe surface of the eyes. A lack of mucus in the tear film is alsoassociated with dry eye syndrome.

As discussed above, the meibomian glands are oil-secreting glandslocated within both the upper and lower eyelids. There are approximately30 to 40 glands along the upper eyelid and approximately 20 to 30 glandsalong the lower eyelid with the ducts for each of the glands openingalong the inner edge of the free margin of the respective lids by minuteforamina through which their secretion is released to prevent the lidsadhering to each other or to the ocular surfaces. An example of thelocation of the meibomian glands is illustrated in the cross-sectionalview of the upper eyelid UL shown in FIG. 1A which illustrates therelative positioning of a single meibomian gland MG. Other glands andanatomical features are illustrated for reference, e.g., the glands ofWolfring GW, tarsus TR, gland of Moll GM, gland of Zeis GZ, gland ofKrause GK, upper fornix UF, conjunctiva CN and cornea CR of the eyewhich is partially covered by the upper eyelid UL. As illustrated, themeibomian gland MG is positioned along a length of the upper eyelid UL(and lower eyelid LL) with the duct opening along the inner edge of theeyelid UL in proximity to a surface of the underlying eye.

FIG. 1B illustrates a front view of a patient's eye having the uppereyelid UL and lower eyelid LL in a closed position, such as when thepatient blinks. As shown, the meibomian glands MG may be seen alignedadjacent to one another over both the upper UL and lower eyelids LL.FIG. 1C also shows a perspective view of a patient's eye in the openposition to illustrate how the meibomian glands are typically alignedrelative to one another when the patient's eye is opened.

Blinking is thought to be the primary mechanism to open the orifice ofthe meibomian glands to allow for the release of oil secretions from theglands. The natural blinking motion and blinking force causes the upperlid to pull or drag a sheet of the lipids secreted by the meibomianglands over the two underlying layers of the tear film thus forming theprotective coating which limits the rate at which the underlying layersevaporate. It is estimated that at least 65% of meibomian gland diseaseor dry eye results from a defective lipid layer or an insufficientquantity of such lipids that results in accelerated evaporation of theaqueous layer. Hence, eyelid closure or blinking disorders, or otherdisorders that affect proper tear distribution, may also cause orexacerbate meibomian gland dysfunction or dry eye.

As the eyelids close in a total blink, the superior and inferiorfornices, which hold a reservoir of tears, are compressed by the forceof the preseptal muscles and the eyelids move toward one another. Theupper eyelid, for instance, moves over the eye while exerting upon theeye surface a force which helps to clear the front of the eye of debris,insoluble mucin, and also expresses the oil secretions from themeibomian glands. The lower lid moves horizontally in the nasaldirection and pushes debris toward both punctae, the openings thatultimately drain into the nasal cavities.

As the eyelids open the tear film is redistributed where the upper lidpulls the aqueous phase via capillary action and the lipid layer spreadsas quickly as the eyelids move. Hence, eyelid movement is accordinglyimportant in tear-film renewal, distribution, turnover, and drainage.

For a variety of reasons, the meibomian glands can become blocked,plugged, inflamed, or occluded resulting in meibomian gland dysfunctionand dry eye disease. The obstruction that triggers the disease can occuranywhere within the meibomian gland, for instance, at the gland'ssurface or orifice preventing normal lipid secretions from flowing; inthe main channel of the gland which may be narrowed or blocked; or inother locations deeper within the gland that lead to the main channel.

Treatments for blocked meibomian glands may include a number ofconventional treatments. One course of treatment includes theapplication of soap and cleaning agents, eyelid scrubs, antiseptics, orantibiotics to reduce eyelid inflammation. Antibiotics such astetracycline, doxycycline, minocycline, metronidazole, azithromycin,bacitracin, or erythromycin can be administered orally or topically tohelp regulate or improve meibomian gland lipid production. Inflammationon the surface of the eye may also be controlled with topical drugs suchas corticosteroids or cyclosporine (RESTASIS®, Allergan, Inc., CA), orother anti-inflammatory compounds or immune-suppressants. Evidencesuggests that ocular surface inflammation is not only associated withmeibomian gland dysfunction but also with dry eye syndrome.

Other examples of dry eye treatments may include the application ofprescription eye inserts for people with moderate to severe dry eyessymptoms who are unable to use artificial tears. An eye insert, e.g.,hydroxypropyl cellulose (LACRISERT®, Merck & Co., Inc., NJ), may beinserted between the lower eyelid and eye. The insert dissolves slowlyto release a substance which lubricates the eye. Alternatively, specialcontact lenses or amniotic, membrane transplants may be used to shieldthe surface of the eye to trap moisture.

In other treatments, the patient's tear ducts may be closed to preventthe tear film from draining away from the surface of the eye too quicklyby procedures such as insertion of punctal plugs into the tear ducts orcauterizing the tissues of the drainage area.

Aside from implants or cauterizing treatments, dry eye syndrome may betreated using pharmaceutical agents such as eyedrops, ointments whichcoat the eyes, etc. Artificial tears, gels, ointments, autologous serumtears, or albumin drops have all been employed in the treatment of dryeye.

Additionally, warm compresses are also typically placed over the eyesand are used to restore function to the meibomian glands by melting anylipid plugs as well as incorporating massaging of the lids which mayfurther express meibomian gland contents. However, application of warmcompresses often can require their application two to three times dailyduring which time patients may incorrectly target only one of theaffected lids and are also prevented from seeing out of the treated eyebecause of the compresses. Warm compresses pose multiple issues such asnoncompliance, poor persistence, or high variability. Compresses may betoo hot, further exacerbating inflammation, or they may cool too quicklypreventing adequate therapeutic effect.

Other treatment devices have also been developed which cover the entireaffected eye to apply heat and a massaging force directly to theaffected eyelids. However, such devices, like the compresses, requirethat the patient's eyes be temporarily but completely obstructed duringthe treatment resulting in discomfort, lost productivity, andpotentially lower compliance among patients. Additionally, thesetreatments require visits to a physician or healthcare provider, andthus are labor intensive, inconvenient, expensive, and consequently arenot as well-suited for widespread consumer adoption.

There are also forceps that are used for expressing meibomian glands butthese forceps are not customized or optimized for meibomian glandexpression. Expression of the meibomian glands typically involvesapplication of compressive force to the glands to express the secretionsof the gland, also known as meibum, from the gland orifice. Forinstance, such forceps are neither heated nor dimensionally customizedfor directional expression of meibum.

Accordingly, there exists a need for methods and apparatus which arerelatively simple to routinely use for the patient or physician to useand which also allow for the patient to continue their normalactivities, is non-obtrusive and non-disruptive, and which also takeadvantage of the patient's natural physiological activities tofacilitate treatment and which facilitates meibomian gland expression.

SUMMARY OF THE INVENTION

In treating conditions such as meibomian gland dysfunction or dry eyesyndrome, a patch or strip can be affixed to the skin of the upperand/or lower eyelids to deliver heat or other forms of energy, cooling,light, ultrasound, vibrations, pressure, drugs, moisture, etc. (alone orin combination) to the one or more meibomian glands contained within theunderlying skin. In particular, the assembly for the treatment strip orstrips may generally comprise one or more strips configured to adhere toan underlying region of skin in proximity to one or both eyes of asubject such that the one or more strips allow for the subject to blinknaturally without restriction from the one or more patches. Moreover,the one or more strips may be configured to emit energy or therapy tothe underlying region of skin and where the one or more strips areshaped to follow a location of one or more meibomian glands containedwithin the underlying region of skin.

A programmable controller having a controller board and a processor maybe in communication with the one or more strips, where the controllermay induce, and monitor a programmable temperature of the one or moreheater strips and to provide a treatment therapy. The therapy may beprogramed to maintain a set point, within a known accuracy, (e.g., 42°C. +/−1° C.) above a threshold temperature of e.g., 39° C., and below amaximum temperature of, e.g., 48° C., over a treatment period of 12minutes. Other treatment times may be implemented in other variations;for instance, the treatment time may extend from 1 minute to 60 minutesin other treatment variations.

In use, the one or more strips may be adhered to a region of skin inproximity to one or both eyes of a subject such that the one or morestrips allow for the subject to blink naturally without restriction fromthe one or more patches. While adhered, the strips may treat or emitenergy to the region of skin, where the one or more strips are shaped tofollow a location of one or more meibomian glands contained within theregion of skin. Alternatively, while the strip may not directly overly ameibomian or other ocular or orbital gland, it may deliver energy orabsorb energy from underlying neighboring tissue or vasculature, whichultimately diffuses, or supplies said glands, respectively. In otherwords, heating or cooling the blood supply to the eyelids, meibomianglands, and/or lacrimal glands using these strips may affect theirfunction and metabolism while not necessarily needing to directly overlythem in particular variations.

The upper strip may thus have an upper curved or arcuate periphery whichis shaped to extend and follow the upper (or superior) border of themeibomian glands (such as along or up to the upper eyelid crease) whilethe straightened periphery of the lower edge may be shaped to extend andfollow the lower for inferior) border of the meibomian glands such asalong the free margin of the upper eyelid. Although straightened, thelower edge may be gently curved or arcuate in alternative variations.The lower strip may similarly have an upper straightened periphery toextend and follow the upper (or superior) border of the meibomian glandsalong the free margin of the lower eyelid and a lower curved or arcuateperiphery to extend and follow the lower (or inferior) border of themeibomian glands along the lower eyelid (such as along or up to thelower eyelid crease). Alternatively, the upper periphery of the lowerstrip may also be gently curved or arcuate in alternative variations aswell.

In other words, with the tarsal plate containing the meibomian glands,which span from proximal to distal, the peripheral edges of thetreatment strips may correspond to the distal eyelid margin and proximalperipheral edge and the treatment strips can assume multipleconfigurations. Generally, the peripheral distal edge of the treatmentstrip may be relatively straight or assume a gentle curve either ofwhich can follow the underlying distal eyelid margin and tarsal platewhile having a proximal peripheral edge that is relatively curved toassume the more curved proximal edge of the underlying tarsal plate.

The strips may be used individually for placement upon only the uppereyelid or only the lower eyelid depending upon the desired treatment.Moreover, the lengths of the treatment strips may also be varied totarget individual meibomian glands for providing a targeted treatment,if desired, and as described in further detail herein. Additionally,while the treatment strips may be sized generally, they may also becustom made or sized for a specific individual's eyelid dimensions.

Because of the specific contoured sizes and flexibility of the treatmentstrips the treatment strips may be placed upon the patient to applytherapy to the underlying meibomian glands allowing the patient's eyesto be opened and closed normally without interference from one or bothtreatment strips. Accordingly, the treatment strips contoured size,shape, thickness, and flexibility allow for treatment to occur whilealso allowing for the patient to have one or both eyes remain openedsuch that normal, physiologic blinking can proceed during the course oftreatment. To further reduce the forces on the eyelids, heaters may bedecoupled from the forces acting on their connections (such as wires) bythe addition of multiple turns (e.g., non-linear regions) in theirconnection paths that destabilize loads that would otherwise becommunicated from power supply cabling to the eyelid(s). Rather thanrelying on an application of any type of external force, the treatmentstrips take advantage of the eye's natural mechanism for clearing oilfrom the meibomian glands via blinking. Hence, the treatment strips maybe adhered in place for treatment without any further intervention bythe patient or healthcare provider such that the treatment strips mayapply, e.g., heat energy, to melt or liquefy any waxy or solid meibomiangland obstructions while the eyes remain unobstructed and are allowed toblink naturally. The treatment strips thus allow for the naturalblinking force to clear the glands of the heat-treated softenedobstructions before they have re-solidified unlike other treatmentswhich require that the patient keep their eyes closed or obstructedduring the course of a treatment and prevent or inhibit the patient fromblinking.

The treatment strip may be configured to have a contact layer (e.g.,fabricated from conductive materials such as metals, alloys, porousceramics, engineering ceramics, woods, polymers, composites, foams,polymer foams, fabrics, elastomers, etc.), which may protect the skinfrom burns or any other adverse effects. A second heating layer may bepositioned above the contact layer (or directly in contact against theskin) for generating the heat energy and an insulative layer may bepositioned atop the heating layer for focusing, directing, or reflectingthe heat towards the underlying skin surface as well as to protect thepatient from contact with the heating layer from other parts of thebody. A sensory layer may be positioned on or between any layer toprovide system or therapy monitoring and feedback, e.g., temperature,tissue impedance, muscle activity, etc. Multiple sensors may be used inany single heater, and compared via the controller's processor todetermine heater state, functionality, regional intra-heater variations,inter-heater variations, and positioning relative to the patientinsulating layer may accordingly be fabricated from a variety ofinsulative or reflective materials, e.g., foams, foam tapes, gauze,silicone, microporous polyethylene films, fabrics, polymers, reflectors,etc. for the purpose of directing energy toward the patient, maintainingtherapeutic target temperatures, and reduce therapeutic fluctuationsbased on ambient conditions. An insulting layer may have a thermal load(capacity) to target a thermal response time for the purpose of tuningtemperature variations. For instance, due to the increased thermal mass,the increased heating and cooling times may be considered in thetreatment procedures.

Although the application of heat energy from the treatment strips isdescribed, other variations may alternatively include the application ofusing the treatment strips for cooling of the underlying skin. Ratherthan using the heating layer in an exothermic reaction, the layer may beconfigured to utilize an endothermic reaction, for example, instead toprovide for cooling of the skin. Cooling, rather than heating, may beapplied for conditions such as reducing inflammation, alleviatingallergies or tired eyes, etc. particularly as the patient rests orsleeps. Electromagnetic energy such as light, mechanical energy,vibrations, or ultrasonic energy are some other examples of therapy thatcan be delivered to target tissues. Energy delivery may be continuous orperiodic (cyclical).

Aside from the application of heat energy from the treatment strips, thestrips may also include a layer for the diffusion, directed delivery, orrelease of one or more pharmaceutical, biological, or chemical agentseither alone or in combination with the heat treatment. For instance,the pharmaceutical, biological, or chemical agents may be incorporatedinto the either the contact layer, insulative layer, or in a separatelayer entirely, for transdermal delivery to the meibomian glands or tothe areas surrounding the meibomian glands for additional and/oralternative treatments. In the event that the pharmacological orchemical agent is released during the heat treatment, the heat may helpto improve penetration of any drugs into the underlying skin.

While the treatment strips may incorporate various layers into thestrips to effect various different treatments, the strips may also bevaried in size, shape, contour, etc. depending upon the desiredtreatment areas so long as the treatment strips are contoured or shapedto follow the location of at least one meibomian gland.

While the treatment strips may be applied to one or more of themeibomian glands, variations of the strip may also be used to treatother glands such as the sebaceous glands, e.g., for acne treatment,cosmetic purposes, arthralgias, myalgtas, wound healing, paw,inflammation, premenstrual pain, breast pain and inflammation. Treatmentstrips used to treat acne may utilize different pharmacologicaltreatments. Moreover, the treatment strips may be used to potentiallytreat eye disorders beyond meibomian gland dysfunction.

Yet another example may include use of the treatment strips for treatingdisorders of the lacrimal gland and/or palpebral lacrimal gland, whichare located above the eye. Variously sized treatment strips, such aslacrimal gland strips, which are sized to have a curved upper periphery,may be sized for placement directly over the skin surface above wherethe lacrimal glands are located. The lacrimal glands and/or palpebrallacrimal gland may be treated alone or in combination with the treatmentstrips contoured for treatment of the meibomian glands.

While the treatment strips may be applied over the meibomian glands toapply the heat energy, the treatment does not require the application ofany external force applied by the strip or any other external device butmay utilize the natural blinking of the patient to facilitate treatmentHowever, in additional variations, the treatment strips may beconfigured to apply both the heat treatment as well as an externalforce. Any number of mechanisms may be utilized to apply a pinching orbiasing force to provide for compression of the underlying skin and ofthe meibomian glands during application of the heat therapy.

Aside from a compression force, the strip may be formed with alternativecomponents such as a mechanical, sonic, or ultrasonic, component toimpart vibrational energy or other forms of energy to facilitate theexpression o the meibomian glands and promote oil secretion.Alternatively, electromagnetic radiation such as visible light, redwavelengths, or infrared wavelengths, as examples, can be delivered as acontinuous or cyclical therapy.

In yet another variation, one or both treatment strips may be configuredto incorporate an indicator, e.g., LED light, alarm, vibration element,etc., electrically coupled to a power supply and/or processor to alertthe patient when a prescribed treatment has been completed. This feature(and any of the other features) may be combined with any of the othervariations of the treatment strips described herein as practicable.

With the incorporation of a processor or sensors into the treatmentstrips, treatment times or other parameters such as temperature of thestrips may be programmed, monitored, and optionally shut on or offselectively by the patient or automatically. Moreover, other parameterssuch as the frequency of the heat delivery or other stimulation ortherapy may also be programmed by the processor to provide furtherflexibility in treatment and monitoring.

In treating conditions such as meibomian gland dysfunction (MGD), whichis commonly associated with the evaporative form of dry eye syndrome(DES), the meibomian glands may be mechanically pressed or squeezed toexpress solidified meibum from the glands in order to help treat MGD.Forceps are typically used to apply pressure upon the meibomian glands.The forceps may be modified to create a pressure gradient upon themeibomian glands to direct meibum and any other meibomian glandsecretions towards the meibomian gland orifices. This pressure gradientmay be increased by the optional incorporation of one or more featuresalong the compression surfaces of the forceps. Additionally and/oralternatively, the forceps may be configured to also provide a thermaltreatment, e.g., to the eyelid surfaces to simultaneously melt, soften,or liquefy and express meibum to increase its therapeutic efficacy.

The forceps may be used after (or during) a heat treatment incombination with the heating strips as described herein. Alternatively,the forceps may be used to first apply a heat treatment to melt themeibum plugs contained within the glands and then the forceps may beused to mechanically express the liquefied meibum before itre-solidifies. In another alternative, the forceps may be used to applya thermal treatment and mechanical expression simultaneously toeffectively express the meibum. In treating the meibomian glands, theforceps may also be used to apply heat to other regions, e.g., innereyelids, outer eyelids, or both. However, when the heating strips areused to apply a heat treatment to a patient, the forceps used formechanically expressing, the glands may be configured to separately heatthe glands and/or they may include any number of mechanical features, asdescribed herein, to facilitate mechanical expression.

The forceps described herein may be used to first apply a heat treatmentto melt, soften, or liquefy the meibum plugs contained within the glandsand then the forceps may be used to mechanically express the liquefiedmeibum before it re-solidifies. Alternatively, the forceps may be usedto apply a thermal treatment and mechanical expression simultaneously toeffectively express the meibum. Alternatively, the forceps may becustomized with a single feature, e.g., directional expression or heattreatment but not both. Furthermore, if a thermal treatment (eitherheating or cooling) is employed, it may be delivered before, during, orafter any mechanical intervention, e.g., meibomian gland expression.Moreover, the mechanical intervention and/or heating may be repeated anynumber of times and may be accomplished in any order, alternating,simultaneously, etc.

One variation of the forceps may have a first handle and second handlecoupled at a proximal end and optionally positioned to extend inparallel or at an angle such that a respective first bridge and secondbridge project and optionally curve relative to the handles such that afirst jaw or paddle is aligned in apposition to a second jaw or paddle.The first paddle and second paddle may also be aligned such that arespective first inner surface and second inner surface are angledrelative to one another to impart a directional pressure gradient uponthe contacted tissue for facilitating meibomian gland expression. Thefirst and second paddles may be sized for positioning in proximity tothe eyes and directly upon the eyelids of a patient and the paddles mayalso be spaced apart from one another to allow for the positioning ofthe tissue (e.g., eyelid tissue containing the meibomian glands)in-between. In other variations, the first and second handles may becurved or arcuate provided that the paddles are spaced apart from oneanother.

One or both of the paddles may be suitably sized for application tovarious regions of the body but when configured for treating themeibomian glands, the paddles may have a height ranging anywhere, e.g.,between 1 mm to 20 mm with a length ranging anywhere, e.g., between 1 mmto 50 mm. In one variation, one or both paddles may have a height andlength of, e.g., respectively, 5 mm by 25 mm.

In treating the meibomian glands, one or both paddles may be configuredto heat up to a predetermined temperature range and optionally for apredetermined period of time. In one variation, the forceps may haveheating strips or sleeves which may be attached or secured or otherwiseapplied as separate elements onto their respective paddles. The heatingassemblies, in this variation, may each define a respective first andsecond receiving cavity or channel, such as a sleeve, into which thefirst and second paddles may be inserted or attached. The heatingelements may be in electrical communication with a controller and/orpower supply which may be integrated with the forceps or otherwiseexternally connected or coupled with the heating elements.

The controller may incorporate a processor which is programmable as wellas a power supply which is rechargeable or disposable, if desired. Inyet other variations, the controller may be configured as a mobiledevice such as a computer, smartphone, tablet, etc. which maycommunicate wirelessly with the heating elements or other features ofthe forceps.

Another variation of the forceps may have the heating elementincorporated directly upon or within the paddle. The heating element maybe electrically coupled to the controller and/or power supply and may beattached to the paddle through any number of securement mechanisms,e.g., adhesives, magnetic, clips, fasteners, etc. in either variation,the heating element may be used to generate or remove energy from thecontacted tissue region being treated by the forceps to create anisolated microenvironment where the energy may be delivered for thermaltherapy for diagnosis) and to confine the area under treatment so as toprevent or inhibit surrounding tissues from unnecessary treatment ordamage.

When the heating element is incorporated directly into one or both ofthe paddles, the heating element may be positioned in a number ofdifferent configurations. For example, the heating element may bepositioned upon or beneath the inner surface which comes into contactwith the tissue being treated, mid-way from the inner surface, or uponor beneath an outer surface of the paddle such that the element ispositioned away from the inner surface.

In applying the thermal therapy, the heating element (in one or bothpaddles) may be heated to a temperature which is effective for meltingsolidified meibum, e.g., between 35° C. to 50° C. or preferably between38° C. to 43° C., or more preferably between 41° C. to 43° C. Moreover,the treatment times over which the heated forceps may be applied to thetissue region being treated may also be varied any, e.g., between 0 to30 min., or preferably between 5 to 15 min., or more preferably between10 to 12 min, in treatments where the forceps may be locked andotherwise secured upon the patient. In other variations, the treatmenttime may vary, e.g., between 1 to 2 mins. per eyelid, when the eyelidsare actively treated and monitored by the user or physician.

The respective first inner surface and/or second inner surface may beangled relative to one another to impart a directional pressure gradientupon the contacted tissue for facilitating meibomian gland expressionwhen compressed between the paddles. When the paddies are urged towardsone another, one or both angled inner surfaces may compress the tissuebetween the paddles to create the directional pressure gradient, e.g.,in a direction perpendicular to the direction of the force applied,which may urge the compressed meibum away from the paddles.Additionally, with continued compression of the forceps, a greaterregion of the inner surfaces may become apposed thereby allowing for achanging or dynamic pressure gradient.

One or both of the inner surfaces may define any number of featureswhich facilitate the creation of the directional pressure gradient. Forexample, one or both of the paddle surfaces may define indentations orgrooves, bumps or projections, or grooves or pits or depressions. Withany of these features described, they may be utilized in any number ofcombinations either on the inner surface of a single paddle or bothpaddles. Moreover, any of these surface features are intended, to beutilized in any number of combinations with any of the angled paddlevariations as well as with any of the heated paddle variations in anynumber of configurations.

Aside from surface features on the paddle inner surface, variations inthe paddle shape may also be utilized in any number of combinations. Inany of these varying paddle configurations, any of these shapes may beutilized in a uniform complementary configuration or in any other shapecombinations where a first paddle has a first configuration and a secondpaddle has a second configuration different from the firstconfiguration. Moreover, any of the paddle configurations are intendedto be utilized in any number of combinations with any of the paddleconfigurations have surface features author in combination with any ofthe paddles having varying angled configurations and/or in combinationwith any of the heating element configurations.

In yet another variation, one or more optional sensors may be positionedalong the heating elements or paddles. The sensors may comprisetemperature sensors, such as thermocouples or thermistors, while othersensor types (e.g., chemical sensors, oxygen, blood flow, force,pressure, etc.) may also be utilized in other variations. Such sensorsmay be incorporated along, the paddles alone or in any number ofcombinations with any of the variations described, herein.

Additionally, any of the paddles may also incorporate any number ofdrugs (e.g., anesthetics, antibacterial agents, etc.) upon the paddlesurfaces or through delivery mechanisms which may be infused or placedupon the tissue when contacted by the forceps.

Furthermore, any of the forceps variations and combinations describedherein may be used alone for treating a patient or they may be used incombination with any of the treatment apparatus and methods described infurther detail in U.S. patent application Ser. No. 13/645,985 filed Oct.5, 2012 and U.S. patent application Ser. No. 13/343,407 filed Jan. 4,2012, which are each incorporated herein by reference in its entiretyand for any purpose herein, particularly for treatment of MGD and dryeye syndrome.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a cross-sectional side view of an upper eyelid and anexample of the location of a meibomian gland.

FIG. 1B shows a front view diagram of meibomian gland distribution inhuman eyelids having the upper eyelid and lower eyelid in a closedposition, such as when the patient blinks, and the alignment of themeibomian glands over both the upper and lower eyelids.

FIG. 1C shows a perspective view of a patient's eve in the open positionto illustrate how the meibomian glands are typically aligned relative toone another when the patient's eye is opened.

FIG. 2A shows a front view of a patient's eye in a closed position withan example of treatment strips which adhere onto the upper or lowereyelids (or both) and where the strips are sized or contoured forplacement directly over the meibomian glands located in the underlyingeyelids.

FIG. 2B shows the treatment strips of FIG. 2A illustrating how thestrips may remain adhered to the patient skin while allowing for theeyelids to retract and allow for the patient to continue blinking whileviewing normally out of the eye. While the strips may be applied fromeyelid margin to eyelid crease, they may alternatively flex or accordionand/or compress during blinks to prevent impairment of normal blinkingand maximize comfort.

FIG. 3A shows an example of a contoured treatment strips.

FIG. 3B shows an example of a cross-sectional side view of a treatmentstrip.

FIG. 3C shows another variation of a treatment strip which mayoptionally incorporate sensory capabilities that feed into a controller.

FIG. 3D shows yet another variation where a treatment strip may beformed into a zigzag or curved configuration to facilitate the blinkingby the patient.

FIG. 4 shows a front view of another variation of the treatment strip,which is relatively thin and positioned over the upper eyelids.

FIG. 5 shows a front view of another variation of the treatment stripwhich is relatively thick for treatment of the targeted meibomian glandsas well as the surrounding tissue.

FIG. 6 shows a front view of another variation of the treatment stripwhich is contoured to more closely follow the meibomian glands in theupper eyelids.

FIG. 7 shows a front view of another variation of the treatment stripwhich may be formed into shortened strips for selective placement alongthe eyelids.

FIG. 8 shows a front view of another variation of the treatment stripwhich is relatively thin and contoured for placement along the lowereyelids.

FIG. 9 shows a front view of another variation of the treatment stripwhich is relatively thicker and also contoured for placement along thelower eyelids.

FIG. 10 shows a front view of another variation of the treatment stripwhich is relatively thick for placement along the lower eyelids.

FIG. 11 shows a front view of another variation of the treatment stripwhich is contoured for the lower eyelids and which may be shortened intovarious lengths.

FIG. 12 shows a front view of another variation of the treatment stripwhich is relatively straightened and selectively shortened.

FIG. 13 shows a front view of another variation of the treatment stripwhich is contoured and further illustrates how differently sized stripsmay be used in combination with one another.

FIG. 14 shows a front view of another variation of the treatment stripwhich is sized to fellow not only the meibomian glands along the lowereyelid but also the surrounding tissue regions.

FIG. 15 shows a front view of another variation of the treatment stripwhich is contoured to follow the meibomian glands along the lower eyelidalong with the surrounding tissue regions.

FIG. 16 shows a front view of yet another variation where the strip iscontoured to follow at least a portion of the meibomian glands but alsoto cover selected regions of the surrounding tissue.

FIG. 17 shows a front view of yet another variation which is contouredto selectively treat particular regions of the underlying tissue.

FIG. 18 shows a front view of yet another variation where the contouredtreatment strips may be used in combination for treating both upper andlower eyelids.

FIG. 19 shows a from view of yet another variation where the treatmentstrips may be altered in color to more closely match the underlying skintone.

FIG. 20 shows a from view of yet another variation where the treatmentstrips may be sized to treat specified meibomian glands.

FIG. 21 shows a front view of yet another variation where the strips maybe varied in size to selectively treat particular meibomian glands.

FIG. 22 shows a front view of vet another variation where the treatmentstrips may be sized to treat individual meibomian glands.

FIG. 23 shows a front view of yet another variation where the treatmentstrips may be sized for placement along the lower eyelids.

FIG. 24 shows a front view illustrating the relative positioning of thelacrimal glands.

FIGS. 25 to 27 show variations of treatment strips which may becontoured and positioned for treating the underlying lacrimal glands.

FIGS. 28 to 30 show variations of treatment strips which may becontoured and sized for treating, the meibomian glands in combinationwith optionally treating the lacrimal glands as well.

FIGS. 31 and 32 show variations on treatment strips which may be sizedfor selectively treating particular meibomian glands in combination withthe lacrimal gland.

FIG. 33 shows another variation of a treatment strips which may havemechanically biasing features incorporated along, the strips forapplying a force to the underlying tissue and meibomian glands.

FIG. 34 shows a detail perspective view of the treatment strip of FIG.33 illustrating an example of biasing mechanisms incorporated along thestrips.

FIG. 35 shows another variation of treatment strips incorporating one ormore transducers for imparting a vibrating force to the underlyingtissue and meibomian glands.

FIG. 36 shows yet another variation of treatment strips incorporatingelectrodes through the length of the strips.

FIG. 37 shows yet another variation of treatment strips incorporatingmicrowave antennas, inductive coil, or technology that allows forwireless powering of the strips without physical connections to thecontroller.

FIG. 38 shows yet another variation of a treatment strip incorporating atimer and indicator for alerting a user when a treatment has beencompleted.

FIG. 39 shows yet another variation of an eyelid treatment system whichmay be coupled to a portable remote controller such as a smartphone ortablet.

FIG. 40 shows a perspective view of a controller which is specificallydesigned and programmed for use with the treatment strip assemblies.

FIGS. 41A and 41B show perspective views of the controller havingconnectors for respective treatment strip assemblies coupled to thecontroller.

FIGS. 42A and 42B show perspective views of the controller with thehousing shown as transparent for clarity purposes to illustrate some ofthe internal components.

FIG. 43 shows a perspective view of a charging station which provides areceiving cradle for holding the controller.

FIG. 44 shows the mating connection of a treatment strip assembly to are-usable cable assembly.

FIG. 45A shows a perspective view of treatment strip assembly coupledvia respective connectors to a common junction for attachment to acable.

FIG. 45B shows a perspective view of a treatment strip with a sensinglayer exposed, illustrating the positions of various sensors.

FIG. 46 shows a perspective view of one variation of the forceps whichare sized and angled for expressing the meibomian glands.

FIG. 47A shows a side view of another variation where heating strips maybe applied upon or over the jaws or paddles of the forceps.

FIG. 47B shows a side view of another variation where the heatingelement may be applied directly upon the face of the jaws or paddles.

FIGS. 48A and 48B show perspective and end views where the heatingelement may be positioned upon or in proximity to the inner surface ofthe jaw or paddle.

FIGS. 49A and 49B show perspective and end views where the heatingelement may be positioned within the jaw or paddle.

FIGS. 50A and 50B show perspective and end views where the heatingelement may be positioned upon or in proximity to the outer surface ofthe jaw or paddle.

FIGS. 51A and 51B show perspective and end views of another variationwhere the jaw or paddle may be angled relative to one another tofacilitate meibomian gland expression.

FIGS. 52A and 52B show end views of variations of the jaws or paddleswhich may be angled relative to one another to facilitate meibomiangland expression.

FIGS. 53A to 53E show perspective views of several variations of theface of the jaw or paddle which may incorporate various features tofacilitate meibomian gland expression.

FIGS. 54A to 54D show perspective views of various forceps jaw or paddleconfigurations which may be used.

FIGS. 55A to 55E show perspective views of additional forceps jaw orpaddle configurations which may be used.

FIG. 56 shows a perspective view of another forceps variationincorporating one or more sensors such as temperature sensors.

FIG. 57 shows a perspective view of a forceps variation incorporating areservoir for fluid collection.

FIG. 58 shows an example of a treatment kit which includes forceps andoptionally included additional treatments.

FIG. 59A shows another example of a treatment kit which includes forcepsand one or more heating strips.

FIG. 59B shows another example of a treatment kit which includesforceps, one or more heating strips, and optionally a controller.

DETAILED DESCRIPTION OF THE INVENTION

In treating conditions such as meibomian gland dysfunction (MGD), whichis commonly associated with the evaporative form of dry eye syndrome(DES), a patch, strip or thin adhesive device can be affixed to the skinof the upper and/or lower eyelids to deliver or absorb heat or otherforms of energy, pressure, drugs, moisture, etc. (alone or incombination) to the one or more meibomian glands contained within theunderlying skin. In particular, the treatment strip or strips may beconfigured and sized specifically for placement over one or moretargeted meibomian glands contained within the skin of the upper and/orlower eyelids.

The application of thermal therapy, e.g., heating or cooling, can crossthe eyelids quite easily as the eyelids are generally the thinnest skinfound on the human body and the tissue is highly vascularized. With theroot of the eyelid located proximally and the eyelid margin locateddistally, the net arterial flow of blood flows from proximal to distal.So wherever these treatment strips are placed, the heating or coolingtherapy may easily be carried throughout the eyelid and any structurescontained therein, e.g., meibomian glands MG, lacrimal glands LG, glandof Zeis GZ, gland of Moll GM, gland of Wolfring GW, gland of Kraus GK,etc.

Moreover, because the eyelid is so thin, the heating or cooling therapycan be transmitted to the ocular surface and the eye itself (describedin further detail below). Thus, the therapy can impart energy to theconjunctiva, goblet cells, episcleral vasculature, cornea, aqueoushumor, iris, ciliary body, and possibly the retina, choroid, opticnerve, anterior vitreous, and lens. Thus, any thermal therapy by thetreatment strips may also impact and be used to treat ocular surfacedisorders and anterior segment diseases, e.g., conjunctivitis,keratitis, keratopathy, iritis, cyclitis, glaucoma, cataract, etc. Also,there may be use in the postoperative state-like after LASIK, PRK, orcataract or corneal surgery or other ocular, peri-ocular, intraocular,or eyelid surgery, as described in further detail below.

As shown in the front view of FIG. 2A and FIG. 2B, one variation of suchtreatment strips may be seen as being adhered temporarily upon the uppereyelid UL and lower eyelid LL over an eye of a patient P when closed forillustrative purposes. The contoured upper strip 10 may be sized foradherence directly upon the skin of the upper eyelid UL such that thestrip 10 has a configuration and shape which follows the location of theone or more meibomian glands contained within the underlying skin of theupper eyelid UL. Likewise, the contoured lower strip 12 may also have aconfiguration and shape which follows the location of the one or moremeibomian glands contained within the underlying skin of the lowereyelid LL in other variations, the contoured strip may stop at theeyelid, crease or cross over it as described in other variations below.

The upper strip 10 may thus have an upper curved or arcuate periphery 14which is shaped to extend and follow the upper (or superior) border ofthe meibomian glands (such as along or up to the upper eyelid crease)while the straightened periphery 16 of the lower edge may be shaped toextend and follow the lower (or interior) border of the meibomian glandssuch as along the free margin of the upper eyelid UL. The lower strip 12may similarly have an upper straightened periphery 20 to extend andfollow the upper (or superior) border of the meibomian glands along thefree margin of the lower eyelid LL and a lower curved or arcuateperiphery 18 to extend and follow the lower (or inferior) border of themeibomian glands along the lower eyelid LL (such as along or up to thelower eyelid crease). The use of the terms lower and upper herein referto the periphery of the treatment strips when placed upon the patient P(human or animal) and are used herein for descriptive purposes.

While the treatment strips 10, 12 are both shown adhered upon therespective upper eyelid UL and lower eyelid LL, the strips 10, 12 may beused individually for placement upon only the upper eyelid UL or onlythe lower eyelid LL depending upon the desired treatment. Moreover, thelengths of the treatment strips 10, 12 may also be varied to targetindividual meibomian glands for providing a targeted treatment, ifdesired, and as described in further detail herein.

While the treatment strips 10, 12 are shown placed upon the closedeyelids of the patient P, the strips 10, 12 are arc-shaped or flexibleenough to assume the curvature of the patient's eyelid margin and may belong enough to cover some or all of the underlying meibomian glands inthe tarsal plate. While the treatment strips 10, 12 may be sizedgenerally, they may also be custom made or sized for a specificindividual's eyelid dimensions or shaped to optimize adhesion and/orcomfort and/or stability. Generally, the treatment strips 10, 12 mayhave a length anywhere from about 1 mm to 50 mm depending upon thedesired treatment length as well as the anatomical considerations of thepatient since the typical palpebral fissure length in an adult is about27 mm to 30 mm. Thus, to cover as many as all of the meibomian glands,the treatment strips 10, 12 may be sized to have length of, e.g., 25 mmto 30 mm, or if sized to cover just beyond all the meibomian glands, alength of, e.g., 30 mm to 50 mm (or more if needed to optimizecoverage/adhesion/comfort/stability). Moreover, one or both treatmentstrips 10, 12 can have a width ranging anywhere from about 1 mm to 25 mmsince the typical eyelid crease in a Caucasian male is about 8 mm to 9mm above the eyelid margin while in Caucasian females it is about 9 mmto 11 mm above the eyelid margin for more if needed for adhesion/comfortand potentially increased efficacy from heating or cooling the inboundblood flow). Customization enables it to fit any particular anatomy,race, ethnicity, etc. Moreover, the treatment strips may be manufacturedwith varying levels of flexibility to accommodate the ergonomics of theeyelid and eyelid blink for optimal comfort and minimal obtrusiveness ormovement.

Because of the specific contoured sizes and flexibility of the treatmentstrips 10, 12, the treatment strips may be placed upon the patient P bythe patient himself/herself for consumer use or by a healthcare providerto apply therapy to the underlying meibomian glands allowing thepatient's eyes to be opened and closed normally, as shown in FIG. 2B,without interference from one or both treatment strips. While the stripsmay be applied from eyelid margin to eyelid crease, they mayalternatively flex or accordion and/or compress during blinks to preventimpairment of normal blinking and maximize comfort.

Typical treatment patches, such as for application of a warm compress,are generally sized for placement over the entire eye or eyes such thatthe patient is unable to open their eyes or blink during a treatmentsession. Yet, because of the strong association between DES and MGD (forinstance, MGD includes the spectrum of MGD, meibomitis, blepharitis, andocular rosacea), natural blinking by an individual is the mechanism bywhich meibomian gland secretions are normally released onto the eyelidmargin and over the tear, in the absence of blinking, the oil containedwithin the meibomian glands remain unexpressed within the glands'terminal ducts and fail to contribute to distribution of the oily layerupon the tears.

Accordingly, the treatment strips 10, 12 contoured size, shape, andflexibility allow for treatment to occur while also allowing for thepatient to have one or both eyes remain opened such that normal,physiologic blinking can proceed during the course of treatment. Ratherthan relying on an application of any type of external force to expressthe oil or obstruction from the glands, the treatment strips 10, 12 takeadvantage of the eye's natural mechanism for clearing oil from themeibomian glands via blinking. Hence, the treatment strips 10, 12 may beadhered in place for treatment without any further intervention by thepatient or healthcare provider such that the treatment strips 10, 12 mayapply, e.g., heat energy, to melt or liquefy any waxy or solid meibomiangland obstructions while the eyes remain unobstructed and are allowed toblink naturally. The treatment strips 10, 12 thus allow for the naturalblinking to help clear the glands of the heat-treated softenedobstructions before they have re-solidified unlike other treatmentswhich require that the patient keep their eyes closed or obstructedduring the course of a treatment and prevent or inhibit the patient fromblinking. Delivery of heat may also increase blood flow by promotingvasodilation as increased delivery of blood can affect metabolism,temperature of other tissues, may have effects on inflammation, and canthereby improve tissue function or recovery.

Because some patients have obstructions or occlusions in their meibomianglands that may not sufficiently melt, loosen, or soften withoutattaining heightened temperatures at the meibomian glands, the treatmentstrips 10, 12 may apply heat or other treatments to the surface of theeyelids for a significant period of time for relatively longer treatmenttimes and at higher treatment temperatures because of the ability of thetreatment strips 10, 12 to remain attached to the patient during anygiven period throughout the day. Treatment strips may be relativelytransparent or skin toned, and thereby inconspicuous, to allow fornormal functioning throughout the treatment ranges. Patients can assumetheir daily activities with their eyes open and eyes blinking and withthe comfort of a strip-based treatment. Moreover, patients can affix thetreatment strips as many times as needed throughout the day, week,month, etc. until dry eye symptoms subside. This increases the frequencyof treatment, convenience of treatment, and thus efficacy of treatment.

Because of the prolonged treatment times, the application of a separateforce beyond the application of the strips may not be needed so long asthe patient is able to continue blinking during, the course oftreatment. Moreover, the treatment frequency may be adjusted or varieddepending upon the severity of the condition to be treated. One examplefor potential treatment frequency may include application of one or bothstrips, e.g., up to six times per day for ten minutes or up to an houror more for each treatment. Moreover, because the treatment strips arepositioned over the meibomian glands which overlie the ocular surfaces,the application of the heating therapy may also indirectly heat theocular surface as well and may further reduce any chronic ocular surfaceinflammation, chronic conjunctival inflammation, or cornealneovascularization.

Aside from heating of the ocular surface, heat therapy may alsooptionally be used to potentially provide for indirect heating throughthe ocular surface as well for heating of the retina to provide athermal therapy to limit inflammation and neovascularization which areunderlying conditions for diseases such as age-related maculardegeneration (AMD), retinal vascular occlusions, retinalneovascularization, glaucoma, retinal degenerations and dystrophies, andDiabetic Retinopathy.

While the treatment strips 10, 12 may be used throughout the day to takeadvantage of the patient's physiologic blinking, the treatment strips10, 12 may also be used while the patient is resting or sleeping orwhile the patient simply maintains their eyes closed. The treatmentstrips 10, 12 may applied as a single-use treatment or they may beconfigured to be robust enough as a re-usable device.

The treatment strips 10, 12 are desirably flexible enough to accommodatemovement of the upper eyelid UL and/or lower eyelid LL which may move asmuch as about 15 mm or more. Thus, the treatment strips 10, 12 may befabricated from various materials. FIGS. 3A and 3B show front andcross-sectional side views, respectively, in one example of a treatmentstrip configured to have an adhesive 32 positioned about a periphery ofthe strip to leave a contact region 30 for direct placement against theskin surface. The contact region 30 may further include a moisturizinglayer to interface between the strip and skin to facilitate beattransfer from the strip as well as to provide moisturizing therapy tothe skin. Alternatively, the treatment strips may be used with anynumber of moisturizing agents which may be applied to the underlyingskin by the patient P or by a practitioner separately from the treatmentstrips. Moreover, the contact region 30 may be formed to have a surfacewhich is smooth, porous, irregular, corrugated, etc. to facilitatecontact and transfer of the heat from the treatment strip to the skinsurface. Alternatively, the entire contact region 30, including itsperiphery, may be adhesive to maintain good contact. It may be hinged orcurved to allow flexing or accordion-like dynamic movement for comfortand better, physiologically-sound ergonomics. In use, the strip may beapplied under tension, as shown by the tensioned strip 10′ in FIG. 3D,to further reduce any impairment to blinking and once adhered to theskin the strip may be released to allow for its flexion, as shown by thereleased strip 10″ also in FIG. 3D, to facilitate blinking, by thepatient P.

In this variation, the treatment strip 10 may be configured to have acontact layer 34 (e.g., fabricated from conductive materials such asmetals, alloys, porous ceramics, engineering ceramics, woods, polymers,composites, foams, polymer foams, elastomers, etc.) which may protectthe skin from burns or any other adverse effects. Such a contact layer34 may also be comprised of a single-use adhesive layer, soft stickypolymeric material, etc. A second heating layer 36 may be positionedabove the contact layer 34 or directly in contact against the skin) forgenerating, the heat energy and an insulative layer 38 may be positionedatop the heating layer 36 for focusing, directing, or reflecting theheat towards the underlying skin surface as well as to protect thepatient from contact with the heating layer 36 from other parts of thebody. The insulative or reflective layer 38 may accordingly befabricated from a variety of insulative or reflective materials, e.g.,foams, foam tapes, gauze, silicone, microporous polyethylene films,metals, alloys, reflective materials, mirrors, etc. Moreover, thethickness of the treatment strip 10 may vary, e.g., anywhere from about1/64″ to ⅛″ (about 0.397 mm to 3.175 min) or more, depending upon theheating layer 36 mechanism as well as the desired thermal profile andtargeted transmission temperature. Additionally and/or alternatively,the insulative layer 38 may be comprised of a thermochromic materialwhich may change its color when a targeted temperature has been reachedby the treatment strip 10 to indicate to the patient that the targetedtemperature has been achieved or when the therapy has been completed.With an insulative layer 38, due to the increased thermal mass, theincreased heating and cooling times may be considered in the treatmentprocedures.

The heating layer 36 may be configured to generate its heat energy,e.g., up to a temperature range of about 20° to 55° C. (or more) orbetween 40° to 50° C., through any number various mechanisms such asmechanical, electrical, or chemical mechanisms. In one variation, theheating layer 36 may comprise an air-activated or oxygen-activatedwarmer that can increase to an elevated treatment temperature for aperiod of time lasting, e.g., from 5 minutes up to 24 hours or evenlonger. An example can include air activated layer incorporating, e.g.,iron. Other examples may incorporate a heating layer 36 containing,e.g., cellulose, iron powder, water, activated carbon (to speed upreaction), vermiculite (water reservoir), and salt (catalyst), saw dust,sodium chloride and water, etc. to generate heat from an exothermicoxidation of iron when exposed to air. Other variations may comprise aheating layer 36 which incorporates light-based activation (visible orUV-light powered) or use of a supersaturated solution(crystallization-type) to initiate and/or maintain an exothermicreaction.

Optionally, aside from use of a thermochromic material to determine whenthe treatment strip has reached a particular temperature, a separatetemperature sensor 39 (e.g., thermocouples or thermistor devices) may beincorporated onto the treatment strip 10, as shown in FIG. 3B, attachedeither to the top of the strip or to the bottom of the strip. Thetreatment strip 10 may also incorporate an optional controller and/ordisplay 37 having a processor which may be programmable and which mayincorporate a separate on/off feature, as shown in FIG. 3C. Thetemperature sensor(s) 39 may be in communication with the controller 37which may be programmed to regulate the temperature of the heating layer36 and/or a length of time for a particular treatment. Sensors canprovide data to the controller demonstrating any regional variations intemperature, which improve ability to remain in the therapeutic windowand also notify a user of suboptimal adherence or heating stripdetachment. Multiple temperature sensors may used to determine thecorrect application of the strip to the patient, e.g., a sensor not incontact with the patient will register a different temperature comparedto a sensor in contact with the patient. The controller 37 mayaccordingly be programmable by a physician or caregiver or directly bythe patient. Alternatively, the controller 37 may be configured to beinaccessible by the patient but may merely provide temperature and/ortime indications for display to the patient. In the event that thecontroller 37 is programmable, the controller 37 may be programmed,e.g., to set a length of a heating period, set treatment times, setpredetermined temperature ranges, control a heating temperature profile(such as gradually increasing the heating temperature or decreasingtemperature over a predetermined period of time), etc.

In another variation, the heating layer 36 may generate heat throughexothermic crystallization of supersaturated solutions (typically sodiumacetate) which are usually reusable. The treatment strips may berecharged by heating them, e.g., by boiling, and allowing them to cool.Heating of these treatment strips may triggered by snapping a smallmetal device buried in the treatment strips which generates nucleationcenters that initiate crystallization. Heat is required to dissolve thesalt in its own water of crystallization and it is this heat that isreleased when crystallization is initiated.

In yet another variation, the heating layer 36 may comprise a batteryoperated warmer which utilizes electrically resistive heating elementsthat are used to convert electrical energy in the battery to thermalenergy. The power supply may be internal or external to the treatmentstrips and the treatment strips may charged, e.g., by direct electricalcontact, induction, etc.

Other mechanisms which may be incorporated into the heating layer 36 maycomprise chemically actuated reactions such those used by sodium acetateheating pads. For instance, a single-use chemical reaction utilizing thecatalyzed rusting of iron or dissolving calcium chloride may be usewhere the reagents are maintained in separate compartments within thetreatment strips. When the patient squeezes the treatment strips, thecompartments may break and the reagents mixed to produce heat. Examplesmay include use of a supersaturated solution of sodium acetate NaCH₃COO)in water where crystallization may be triggered by flexing a small flatdisc of notched ferrous metal embedded in the liquid which act asnucleation sites for the crystallization of the sodium acetate into thehydrated salt (sodium acetate trihydrate). Because the liquid issupersaturated, this makes the solution crystallize suddenly [rapidly?]which releases the energy of the crystal lattice.

Yet another example of use in the heating layer 36 may include the useof a hot gel containing a supersaturated solution of a salt. Heat may begenerated when the crystallization of the given salt occursexothermically. Such heating layer 36 may be reused by forcing the saltback into solution within the heating layer 36.

Yet other examples for incorporation into the heating layer 36 may alsoinclude the use of high specific heat capacity materials which may beheated, e.g., by placement in a microwave prior to use, and then allowedto release the heat over a specified period of time.

Although the application of heat energy from the treatment strips isdescribed, other variations may alternatively include the application ofusing the treatment strips for cooling of the underlying skin. Ratherthan using the heating layer 36 in an exothermic reaction, the layer maybe configured to utilize an endothermic reaction instead to provide forcooling of the skin at temperatures ranging, e.g., from about 0° C. to37° C. or more particularly from about 25° C. to 35° C. One example mayinclude having the layer 36 to incorporate water and ammonium nitrate orammonium chloride. Mixture of the water and the ammonium may reduce thetemperature of layer 36. Another variation may include the use ofcooling gel made by adding hydroxyethyl cellulose or vinyl-coated silicagel which may be cooled or frozen prior to use. Alternatively, cooling,including but not limited to thermoelectric cooling, may be achieved byapplication of a cooling element such as a Peltier junction. Cooling,rather than heating, may be applied for conditions such as reducinginflammation, swelling, alleviating allergies or tired eyes, etc.particularly as the patient rests or sleeps. One example includestreatment for allergic conjunctivitis where application of the coolingtreatment may provide relief from any burning or itching sensations byserving as a vasoconstrictor to limit blood flow, reduce blood vesselleakage and permeability thereby reducing acute swelling andinflammation. Yet another example includes reducing inflammation andfibrosis of a conjunctival bleb resulting from a trabeculectomy ormitigating inflammation generally following any ophthalmic or periocularsurgical procedure or treatment.

Given the multitude of various mechanisms for incorporating a heatinglayer 36, the treatment strips may be configured to be single-usedisposable strips, multiple-use disposable, re-usable strips,selectively actuatable, etc.

Aside from the application of heat energy from the treatment strips, thestrips may also include a layer for the diffusion or release of one ormore pharmaceutical, biological, or chemical agents either alone or incombination with the heat treatment. For instance, the pharmaceutical,biological, or chemical agents may be incorporated into the either thecontact layer 34, insulative layer 38, or in a separate layer entirely,for transdermal delivery to the meibomian glands or to the areassurrounding the meibomian glands for additional and/or alternativetreatments. For instance, examples of some of the variouspharmacological agents which may be incorporated into the treatmentstrips (for use with or without the heat treatment) may include, but arenot limited to, anti-inflammatory compounds, antibiotics, topicaltetracycline, oral tetracycline, topical corticosteroids, oralcorticosteroids, topical androgens, metronidazole, steroid antagonists,topical androgen analogues. TGF-β, omega 3 or omega 6 compounds,vasoconstrictors such as naphazoline, oxymetazoline, phenylephrine, andtetrahydrozoline, enzymes that promote lipid production, agents thatstimulate production of enzymes that promote lipid production, agentsthat act as a secretagogue to enhance meibomian gland secretion, agentsthat replace or promote production of any tear component, cholinergic,muscarinic, or nicotinic agonists may be used, cosmeceuticals such asretinol or hyaluronic acid (HA) for wrinkled, puffy, or sagging skin inthe cosmetics space, retinoic acid for acne, or agents that degrade orbreak down lipids like lipases, etc.

Other agents may include, e.g., alpha-melanocyte-stimulating hormone oradrenocorticotropic hormone or androgens like testosterone to increasetear production, agents which stimulate the underlying muscles like theorbicularis oculi or muscle of Riolan to stimulate blinking, increasefrequency of blinking, or maintain longer closure after a blink byinhibiting the levator palpebrae muscle to force a blink or eyelidclosure or otherwise mechanically compress the meibomian glands orglands of Zeis or other goblet cells or accessory lacrimal glands.

Additionally and/or alternatively, other agents for incorporation intothe treatment strips may further include, e.g., neurotransmitters,noxious or irritating chemicals or vapors, hormones, oils, lipids, polarlipids, or fatty acids. Use of neurotransmitters may allow forstimulation to occur via second messenger pathways like activation ofthe Calcium/Protein Kinase C pathways, G-Protein activation, othercalcium related pathways, calcium-calmodulin dependent protein kinases,the cyclic adenosine monophosphate dependent pathways, adenylyl cyclasepathways, inhibition of cAMP dependent phosphodiesterases.

In the event that the pharmacological or chemical agent is releasedduring the heat treatment, the heat may help to improve penetration ofany drugs into the underlying skin.

Yet another variation may incorporate a treatment strip which applies aheat rub that can be applied via the treatment strips onto the upper ULand/or lower eyelids LL for the treatment of the meibomian glands orwhich applies a compound which attracts light and heats up accordingly.Each of these variations may allow for the treatment strips 10, 12 to beapplied and used while allowing for natural blinking to occur tofacilitate the clearing of the ducts of melted oil blockages within themeibomian glands and to thcilitate the spreading of the oil onto thetears.

While the treatment strips may incorporate various layers into thestrips to effect various different treatments, the strips may also bevaried in size, shape, contour, etc. depending upon the desiredtreatment areas so long as the treatment strips are contoured or shapedto follow the location of at least one meibomian gland. An example ofanother configuration for the treatment strips is shown in the frontview of FIG. 4, which illustrates a contoured thinned strip 40 sized andshaped for placement along the upper eyelid UL. This treatment strip mayhave a contoured lower edge 42 as well as a contoured upper edge 44which follow the positioning of the underlying meibomian glands.Moreover, although the strips 40 are shown placed upon the upper eyelidsUL of both eyes of the patient P, a single strip 40 may be used upon asingle eyelid to selectively treat the particular meibomian glands inthis and other examples shown herein. Additionally, one or both uppereyelids UL may be treated alone or in combination with one or both lowereyelids LL depending upon the desired treatment in this and otherexamples shown herein.

Another variation is shown in the front view of FIG. 5 which shows acontoured thickened strip 50 having a contoured lower edge 52 andcontoured upper edge 54 for placement upon the meibomian glands as wellas the surrounding tissue and glands. In yet other variations, ratherthan utilizing two separate treatment strips, a singular strip may alsobe used which extends over the bridge of the patient's nose.Additionally, the thickened strip 50 may cover the portions of skinfarther proximally away from the eyelid margin to facilitate treatment.Because arterial blood supply to the eyelids proceed from proximal todistal of the eyelid margins, the treatment strip may heat (or cool) theblood supply as it continues to flow towards the eyelid margins. Thisearly heating (or cooling) may provide a therapeutic effect forincreased comfort to the patient, less impact on eyelid function (suchas blinking), and increased safety of application and distance from theocular surface as well as potentially increased efficacy allowing formore total heating or cooling therapy.

FIG. 6 shows yet another variation having a contoured thinned strip 60where the lower 62 edge and upper edge 64 converge to a tapered end 66for placement upon the meibomian glands. FIG. 7 shows yet anothervariation where the treatment strips may comprise straightened strips 70having a first width used in combination with a thinned straightenedstrip 72 as well. The straightened strips 70 may comprise straightenedstrips (having optionally rounded corners) which may be selectivelyplaced over the meibomian glands. In this example, a single straightenedstrip 70 may be applied upon the upper eyelid UL of a single eye whilethe remaining eye may utilize a single straightened strip 70 appliedalong a first portion of the upper eyelid UL and a second straightenedstrip 72 having a relatively thinner width for placement upon a secondportion of the upper eyelid UL. Each of the strips may be appliedsingularly or in various combinations depending upon the desiredtreatment areas and are shown in this variation as an exemplarycombination.

In the variation of FIG. 8, an example of contoured thinned strip 80 isshown applied along the lower eyelid LL. As illustrated, the contouredupper edge 82 and contoured lower edge 84 may be contoured to followover the underlying meibomian glands. As described above, the treatmentstrips may be applied singularly over one or both eyes or they may beapplied in combination with treatment strips applied over one or botheyes of the upper eyelids. Moreover, any of the treatment strips shownherein may be used in any number of combinations with one another.

FIG. 9 shows another variation where the contoured thickened strip 99may be applied over the lower eyelids LL and may further have a widthwhich is relatively wider than those treatment strips shown above inFIG. 8. Similarly, FIG. 10 shows yet another variation where thecontoured thickened strip 92 may have a width which is relatively widerstill for treating not only the underlying meibomian glands but also anyglands and tissue surrounding the peri-orbital region. As describedabove for the variation of FIG. 5, the widened treatment strip may heat(or cool) the blood supply as it continues to flow towards the eyelidmargins. The early heating (or cooling) may provide a therapeutic effectfor increased comfort to the patient, less impact on eyelid function(such as blinking), and increased safety of application and distancefrom the ocular surface.

Aside from variations in width of the treatment strips, any of thetreatment strips may be varied in length as well to selectively targetportions of the meibomian glands or particularly selected meibomianglands. For example, FIG. 11 shows one variation where the shortenedcontoured strip 100 having a first shortened length may be applied uponthe lower eyelid LL (and/or upon the upper eyelid UL). A secondcontoured strip 102 having a second length which is longer than theshortened contoured strip 100 may also be seen for comparison. FIG. 12similarly shows a shortened and straightened strip 110 applied upon thelower eyelid LL and a second straightened strip 112 having a relativelylonger length applied upon the second lower eyelid LL. The straightenedstrips 110, 112 may incorporate rounded ends and may be varied in lengthdepending upon the desired treatment area. They could also be rounded orcircular to cover one or more styes.

FIG. 13 shows yet another variation where the contoured strips 120 maybe configured to have tapered ends for overlying the meibomian glands.In comparison, thickened contoured strip 122 is also illustrated havingtapered ends yet is relatively wider to alter the treatment area.

FIG. 14 shows another variation where the contoured strip 130 may have afirst portion 132 which is relatively wider than a second portion 134for placement over the meibomian glands of the lower eyelid LL. Each ofthe first 132 and second portions 134 may be varied in width againdepending upon the desired treatment areas. Another example is shown inFIG. 15 which shows a contoured strip 140 having a first portion 142 andsecond portion 144 which are considerably wider for treating not onlythe meibomian glands along the lower eyelid LL but also the surroundingperi-orbital tissue regions such as the underlying maxillary sinus. FIG.16 shows yet another example of a contoured strip 150 having a firstportion 152 and a second portion 154 which is wider than the firstportion 152 and where the strip 150 is positioned to cover just aportion of the meibomian glands along the lower eyelid LL but alsocovers various other glands, such as the lacrimal glands, around theperi-orbital regions.

FIG. 17 shows yet another variation of a treatment strip comprised of acontoured strip 160 having a secondary enlarged portion 162 attached viaa connecting strip 164. While the contoured strip 160 may treat themeibomian glands along the lower eyelid LL, the secondary enlargedportion 162 may treat region of the tissue along the cheeks of thepatient.

In yet another variation, FIG. 18, shows an example where both an uppercontoured strip 170 and a lower contoured strip 172 may be applied,respectively, along the upper eyelid UL and lower eyelid LL. Asdiscussed previously, the contoured strips 170, 172 are shaped andapplied to follow the underlying meibomian glands while enabling thepatient P to blink normally. FIG. 19 shows a similarly applied uppercontoured strip 180 and lower contoured strip 182 where the strips maybe varied in color to more closely match a skin tone or shade of thepatient P. Because the treatment strips may be used throughout the dayfor any given period of time, the strips 180, 182 may be made m variouscolors or tones to either more closely match the skin tone or shade ofthe patient P.

In yet another variation. FIG. 20 shows another example where thetreatment strips may be varied in length to treat specific regions alongthe upper UL or lower eyelids LL. In this example, a first upper strip190 having a first length may be applied adjacent to a second upperstrip 192 having a second longer length. Optionally, a third upper strip194 and/or fourth upper strip 196 having lengths which are relativelyshorter may also be applied as well over selected meibomian glands. Alower strip 198 having enlarged distal ends 200, 202 are also shown forplacement along the lower eyelid LL. The distal ends 200 may be shapedto facilitate the placement and/or removal of the strip 198 from theskin (or for better adhesion). Yet another example is shown in FIG. 21which illustrates several shortened treatment strips, e.g., first upperstrip 210 and second upper strip 212, placed selectively along thetipper eyelid UL along with, e.g., first lower strip 214 and secondlower strip 216, placed selectively along the lower eyelid LL. Each ofthe strips may be varied in length as well as size depending upon thetreatment area.

With the lengths of the treatment strips being variable, multiple stripsmay be applied adjacent to one another or to overlap horizontally and/orvertically along the eyelids. Moreover, one or more of the treatmentstrips may be made as a single unit or as a series of panels eitherhorizontally or vertically oriented which may be optionally connected bya backing that is flexible. As shown in the variation of FIG. 22, eachof the targeted strips 220 may have a length of e.g., about 1 mm, tocover as few as a single meibomian gland. One or more of the targetedstrips 220 may be applied along the upper eyelid UL and/or lower eyelidLL. Additionally, one or more of the targeted strips 222 may furthercomprise a connecting member 224 which functions as a backing to coupleeach of the individual targeted strips 222 to one another. Theindividual strips may be applied selectively at particularly problematicmeibomian glands either along the upper eyelid UL and/or lower eyelidLL. For example, FIG. 23 illustrates the individual targeted strips 222placed along just the lower eyelid LL.

While the treatment strips may be applied to one or more of themeibomian glands, variations of the strip may also be used to treatother glands such as the sebaceous glands, e.g., for acne treatment.Treatment strips used to treat acne may utilize differentpharmacological treatments. Other glands in the underlying eyelids andconjunctiva CN for treatment may also include treatment of e.g., theglands of Zeis GZ, goblet cells, accessory sebaceous glands, accessorygoblet cells such as the Henle and Manz glands, accessory lacrimalglands of Wolfring GW or Krause GK, or either one or both lobes of themain lacrimal glands such as the palpebral portion or the orbitalportion.

Moreover, the treatment strips may be used to potentially treat eyedisorders beyond meibomian gland dysfunction including, e.g.,blepharitis, sjogren's syndrome, dacryoadenitis, conjunctivitis,allergic conjunctivitis, keratoconjunctivitis sicca, keratitis,dacryocystitis, iritis, keratitis, retinitis, sclerokeratitis, uveitis,contact lens related eye problems, post blepharoplasty or eyelid or eyesurgical procedures (e.g., cataract surgery, LASIK, PRK, etc.), absentor dysfunctional blinks disorders, conjunctivitis, blepharospasm,exposure keratopathy, conical abrasions, recurrent conical erosions,corneal dystrophies, facial nerve palsies or paresis, lagophthalmos, lidmyokymia, infections, styes, chalazion, hordeolum, glaucoma, blebs,trauma, etc.

Yet another example, as mentioned above, may include use of thetreatment strips for treating disorders of the lacrimal gland LG and/orpalpebral lacrimal gland PL which are located above the eye as shown inFIG. 24. Variously sized treatment strips, such as lacrimal gland strips230 shown in FIG. 25 which is sized to have a curved upper periphery,may be sized for placement directly over the skin surface above wherethe lacrimal glands LG are located. Other variations are shown in FIG.26 which illustrates lacrimal gland strips 232 which are relativelythinner in width as well as in FIG. 27 which illustrates lacrimal glandstrips 234 which have curved peripheries ending in tapered ends. Thetreatment strips may deliver heat, e.g., to stimulate the lacrimal glandLG, increase gland metabolism, activity, lacrimation, etc.Alternatively, the treatment strips may deliver cooling therapy toreduce inflammation which impairs gland function.

The lacrimal glands LG and/or palpebral lacrimal gland PL may be treatedalone or in combination with the treatment strips contoured fortreatment of the meibomian glands. One variation is shown in FIG. 28which illustrates contoured strips 240 which are enlarged in width tocover both the lacrimal glands LG as well as the meibomian glands alongthe upper eyelid UL. Contoured treatment strips 242 are also shownplaced along the lower eyelids LL for treatment of the meibomian glandsas well.

FIG. 29 shows another variation where lacrimal gland strips 250 may beplaced over the lacrimal glands LG in combination with an integralcombined contoured strip 252 which is sized to encircle the eyesentirely while following the location of the meibomian glands along boththe upper eyelids UL and lower eyelids LL. This fully encircling designmay also be held in place more tightly against the skin with a strapwhich may encircle the patient's head, if so desired. Another variationis shown in FIG. 30 which illustrates an integral combined contouredstrip 260 which is also sized to encircle the eyes entirely and furtherhaving a width suitable for placement over the lacrimal glands LG.

The lacrimal gland strip 270 may be used in combination with any of thetreatment strips shown herein. Another example is illustrated in FIG. 31which shows lacrimal gland strip 270 used in combination with theindividual strips 222 while FIG. 32 shows yet another example wherelacrimal gland strip 270 may be used in combination with not only theindividual strips 222 but also the strips 220 located along respectivelower eyelid LL and upper eyelid UL.

While the treatment strips may be applied over the meibomian glands toapply the heat energy, the treatment does not require the application ofany external force applied by the strip or any other external device butmay utilize the natural blinking of the patient to facilitate treatment,as described above. However, in additional variations, the treatmentstrips may be configured to apply both the heat treatment as well as anexternal force. Any number of mechanisms may be utilized to apply apinching or biasing force to provide fur compression of the underlyingskin and of the meibomian glands during application of the heat therapy.One example is shown in the front view of FIG. 33 which illustrates abiased treatment strip 280 which may be comprised of a strip 282, aspreviously described, having one or more biasing mechanisms 284positioned along the strip 282. The one or more biasing mechanisms 284may be positioned along either the upper strip or lower strip or both,as shown.

In this example, the biasing mechanism 284 may locally squeeze orcompress the underlying skin to apply a pressure to the meibomian glandsMG to facilitate the clearing of any obstructions, particularly ifapplied simultaneously with the heat treatment. An example of a biasingmechanism 284 is illustrated in the perspective view of FIG. 34 whichshows how the biasing mechanism 284 may generally comprise portions ofthe strip 282 or separate members biased to form corresponding channels286 which are configured to flex in an open or closed configuration.When the strip is initially placed upon the skin, the ends of the stripmay be pulled to open the channels 286 which may then be placed upon theskin surface. As the strip and biasing mechanisms 284 relax, theunderlying skin and meibomian glands MG may be compressed or pinched bythe compression forces 288 induced into the biasing mechanism 284. Thecompressive force maybe applied, for instance, by changing the currentthrough a Nitinol wire to change a length of the wire when the currentis applied. Additionally, the wire can be used to hold strips to theeyelid or to a add compressive force.

Aside from a compression force, the strip may be formed with alternativecomponents such as a mechanical component to impart vibrational energyto facilitate the expression of the meibomian glands and promote oilsecretion. An example is illustrated in FIG. 35 which shows anothervariation of the contoured strip 290A, 290B having one or more vibratingelements 292 (e.g., piezoelectric transducers, electromagneticactuators, eccentrically coupled rotating, elements, etc.) incorporatedalong the strips 290A, 290B, The one or more vibrating elements 292 maybe electrically coupled to a power supply and/or processor 294 alsocontained along, the strips 290A. 290B. Moreover, the vibrational energymay be imparted separately from heat treatment or in combination withthe heat therapy. The power supply may include a micro-battery which canbe rechargeable to deliver microcurrents of energy. Such a micro-batterycan be integrated either on the strips or separately.

Aside from the application of a vacuum or suction, mechanical pressureor vibrational energy, other forms of energy may also be delivered byone or more of the treatment strips. Another variation is illustrated inFIG. 36 which shows an upper contoured strip 300A having a conductiveelement 302 such as a wire integrated along the entire length (or apartial length) of the contoured strip 300A. The conductive element 302may be configured in an alternating pattern or it may be simply alignedalong the length of the strip as shown by conductive element 306 (orelectrically resistive) along the lower contoured strip 300B. Each ofthe conductive elements 302, 306 may be in electrical communication witha respective power supply and/or processor 304, 308. The conductiveelements 302, 306 may be selectively actuated to apply either heatenergy or they may configured to apply radio-frequency (RF) energy,visible light or specific bands or wavelengths thereof, or infraredradiation to the underlying skin and meibomian glands. With respect tothe application of electrical energy, one form of electrical energyapplicable by the treatment strips may include use of a transcutaneouselectrical nerve stimulation feature, e.g., to deliver neuralstimulation to increase tear production. The conductive elements maygenerate the thermal energy via various power sources, e.g., battery,solar cell, kinetic movement, RF, etc.

FIG. 37 shows yet another variation where the contoured strips 310A,310B may be configured to incorporate an electrode or antenna 312coupled to a power supply and/or processor 314 for applying, e.g.,microwave energy to the underlying meibomian glands. Aside from theelectrical or microwave energy, the treatment strips may be configuredto apply yet other forms of energy for treating the meibomian glands.For example, other variations may incorporate actuators or transmittersfor applying ultrasonic, RF, microwave, magnetic, photonic (light energyin the infrared or visible light spectrum), ultrasound powering with areceiver such as a piezoelectric receiver, electromotive force orelectromagnetic radiation powered, thermal, etc. In yet othervariations, the conductive elements may be configured to function aselectromagnetic elements once actuated or the strips may incorporateferromagnetic elements to promote closure of the eyelids. The magneticforce could serve to squeeze the meibomian glands and express the oilyobstruction as the eyes are opened and re-opened when overcoming themagnetic force.

In yet another variation, one or both treatment strips 320A, 320B may beconfigured to incorporate an indicator 324, e.g., LED light, alarm,vibration element, etc., electrically coupled to a power supply and/orprocessor 322 to alert the patient when a prescribed treatment has beencompleted. This feature (and any of the other features) may be combinedwith any of the other variations of the treatment strips describedherein as practicable.

FIG. 39 shows yet another variation where the eyelid treatment system330 may be formed into a coupled dual-strip design, e.g., a “wishbone”design, where the dual-strip heating strips may have two heatingelements which follow the location of the meibomian glands the upper ULand lower LL eyelid of a single eye. Depending upon whether both eyes ora single eye and/or both upper and lower eyelids are treated, the system330 may comprise a first heating strip assembly 332 and a second heatingstrip assembly 334 for each respective eye. Each of the assemblies 332,334 may accordingly utilize an upper and a lower lid treatment heater,e.g., upper lid treatment strip 332A and lower lid treatment strip 332B,where each of the upper and lower elements may be coupled to one anothervia wires 336 (e.g., flexible circuit). Moreover, each of the assemblies332, 334 may be coupled via a connecting cable 338 to controller 340which may be coupled (e.g., through an input/output port such as aheadphone jack, USB port, micro HDMI, or other connection port) to aportable electronic device 342 (e.g., smartphone having a touch screeninterface, tablet, PDA, laptop computer, etc.) as shown.

In other variations, the number of connecting cables may range anywherefrom 1-4 connector cables rather than utilizing a single cable 338. Forinstance, one cable may be used to provide power and communication to afew or all four heating elements in each of the assemblies 332, 334.Alternatively, four connecting cables may provide power andcommunication to each of the heating, elements in assemblies 332, 334.Yet in other alternatives, two connecting, cables may provide power andcommunication to each of the assemblies 332, 334.

In other additional variations, any of the treatment strips describedmay be used in combination with the controller 342 described herein, aspracticable. Yet in a further variation, oval or circular shaped heatingelements may cover the eye and both eyelids where an outer border of theheating elements or strips may follow the path of the upper and lowermeibomian glands. In this case, one treatment strip may cover botheyelids and both sets of meibomian glands and the user may use a totalof two (rather than four) round, circular, or oval shaped treatmentstrips to cover both eyes. Such a variation may be used, e.g., for anight time therapy in bed prior to or during sleep when the eyes neednot necessarily be open.

The assemblies 332, 334 may generally comprise strips, as previouslydescribed, which follow the location of the meibomian glands while stillallowing patients to blink easily and proceed in comfort with dailyactivity. An example of such heaters which may be configured for usewith the treatment system 330 may include thin, flexible heaters whichare commercially available through companies such as Minco Products,Inc. (Minneapolis, Minn.) or can be custom designed and manufacturedindependently or through third party manufacturing. Each individualtreatment strip, e.g., treatment strips 332A, 332B, may each be sizedfor a single eyelid, e.g., 28 mm×7 min×0.15 mm, having a bottom chordlength of, e.g., 28 mm, with a radius of curvature of, e.g., 75 mm, andhaving a general configuration of an arcuate rectangle having bluntedcorners where the nasal or temporal edges may coincide with the radii ofthe arc. However, these size limitations are intended to be exemplaryand not limiting since the treatment strips 332A, 332B may be sized tobe smaller or larger to accommodate different eye anatomies.

Moreover, the individual treatment strips 332A, 332B may be formed asthin, flexible transparent polymers containing the heating elementswhile the contact surface of the strips may be affixed to the respectiveeyelids with, e.g., a disposable adhesive. Other variations may utilizeopaque or colored strips, e.g., Skin-tone colors. Moreover, one or moretemperature sensors may also be integrated into the treatment stripswhere the heating elements and sensors may be routed through theconnecting cable 338 to a power source and/or controller 340 and/orportable electronic device 342, as shown.

Controller 340 may generally comprise a hardware/software platform orunit which may be programmed for controlling the therapy treatments.Accordingly, the controller 340 may include a processor as well as apower supply such as a battery (rechargeable or disposable) forproviding power to the assemblies 332, 334. The power supply withincontroller 340 may be optionally rechargeable separate from the portableelectronic device 342 or the power supply may draw power for theassemblies 332, 334 and processor directly from the portable electronicdevice 342 as well.

In the case where the controller 340 is programmed to provide thetherapy treatment protocols, one or several controls for controlling thetreatments may be built directly into controller 340. The portableelectronic device 342 may interface with the controller 340 to display,in one variation, part of the controls on a screen (e.g., touchscreen)of the electronic device 342 such as controls for starting and/orstopping a treatment. The controller may also have facilities fordetecting when leads are not properly connected, measuring power levels,and measuring temperature levels. Accordingly, there will be thecapability to notify or alert a user should any of these values fall outof range or the ability to prevent initiation of treatment or ceasetreatment until these scenarios are explicitly acknowledged orcorrected. Alternatively, all of the controls may reside on thecontroller 340 while a display on the electronic device 342 may serveprimarily to show or track various results or treatment parameters, andor treatment status. A separate display and controller combination mayalso be used.

In yet another alternative, the all of the controls may reside on thedisplay of the electronic device 342 for controlling the varioustreatment options and parameters rather than on the controller 340. Inthis variation, the electronic device 342, in this example a smartphone,may also provide the power to the treatment strip assemblies 332, 334and may also control the various treatment temperatures and times aswell as receive and display temperature feedback or other physiologicalparameters which may be measured. In this case, the treatment strips332, 334 and connecting cable 338 may be plugged directly into themobile or portable consumer electronic device 342. For instance, theelectronic device 342 may be used to display treatment parameters andcontrols such as an icon or button for initiating therapy. In oneexample, therapy may be initiated by the user through electronic device342 to heat one or more of the strips of one or both of the treatmentstrip assemblies 332, 334. In any of the variations, the electronicdevice 342, particularly in the case of a smartphone or tablet, may havean optional program or application downloaded onto the device whichfacilitates the various control and/or display parameters on theelectronic, device 342 depending upon how the electronic device 342 isused with the controller 340 and assemblies 332, 334. Depending on thevariation, the display and control display may reside on the controller340 itself or on another device separate from the controller 340.

Additionally, the electronic device 342 may also provide a diagnosticfunction to allow the user to test for dry eye and/or to determine howtreatment is progressing either before, during, or after treatment.Accordingly, the electronic device 342 or controller 340 may leverage,e.g., an integrated camera and/or flash/light source, for purposes ofimaging the user's ocular tear film or ocular surface and evaluatingcommonly used tear assessment criteria such as total tear film layerthickness, and/or tear film mucin layer thickness, and/or tear filmlipid layer thickness, and/or tear film aqueous layer thickness, or anycombination thereof. Such a camera may also display or “mirror” stripplacement for evaluation or adjustment by the user or remotely, eithersynchronously or asynchronously. In addition to imaging of the user'stear film and/or ocular surface conditions, the mobile application mayinclude other common methods for diagnosing dry eye such as userquestionnaires related to the user patient's symptoms, discomfort,and/or improvement or worsening of symptoms that can be completed usingthe electronic device's touch screen interface, results stored on theelectronic device 342 or web application or manufacturer's servers,tracked over time for trend evaluation, and possibly shared with theuser's physician.

Moreover, in any of the variations, the controller 340 and/or electronicdevice 342 may be programmed or initiated to heat up the assemblies 332,334 to, e.g., 42.5° C.+/−1° to 2° C. Treatment time may be set to, e.g.,1 to 30 minutes or more such as 60 minutes, and the controller 340and/or electronic device 342 may further be programmed to shut down whenthe allotted treatment time has passed or if the measured temperaturerises above a predetermined, level, e.g., 45° C. Additionally, thecontroller 340 and/or electronic device 342 may also be programmed orset to indicate various treatment parameters e.g. the initiation oftreatment, warming of the heating elements, completion of treatment,errors, battery life, etc.) through any number of visual, auditory, orhaptic indicators.

Additionally, the controller 340 and/or electronic device 342 may beused to store and/or transmit various data such as historical treatmentdata, usage time, total treatment time, temperature data, etc.Furthermore, the controller 340 and/or electronic device 342 maycommunicate wirelessly with a remote server or additional controller,allowing the controller 340 and/or electronic device 342 to also beprogrammed remotely, e.g., by a physician or other party. In yet othervariations, audio and/or visual information (e.g., advertisements,educational media, social media connectivity, or other media) may alsobe displayed upon the controller 340 and/or electronic device 342 whichmay be received from remote servers or various other data may betransmitted to and/or from the controller 340 and/or electronic device342 as well.

In yet other variations, although controller 340 is illustrated as beingcoupled to assemblies 332, 334 via a wired connecting cable 338, othervariations may have controller 340 wirelessly connected with assemblies332, 334. Such a connection may be through any number of wirelessprotocols such as Bluetooth®. RF, etc.

This “precision temperature control” mobile heating therapy system maybe used for heating other parts of the body as well, where the systemremains nearly the same, but the heating element dimensions may bevaried and power requirements may also be changed depending on the totalsurface area being treated, temperature goals, patient comfort, or othersituational specifics.

With the incorporation of a processor into the treatment strips,treatment times or other parameters such as temperature of the stripsmay be programmed and optionally shut on or off selectively by thepatient or automatically. Moreover, other parameters such as thefrequency of the heat delivery or other stimulation may also beprogrammed by the processor to provide further flexibility in treatment.

In yet another variation, the treatment strip assemblies may be usedwith a controller 350 which is specifically designed and programmed foruse with the treatment strip assemblies. An example of such a controller350 is shown in the perspective view of FIG. 40 which illustrates thecontroller 350 which may comprise a housing 352, e.g., acircularly-shaped housing which may weigh less (or more) than 8 ounces,which encloses the power supply and controller board having aprogrammable processor contained within. The controller housing 352 mayincorporate two ports 354 for plugging two heater assemblies, i.e., afirst port for connecting a first treatment assembly for the first eyeand a second port for connecting a second treatment assembly for thesecond eye, although in other variations, a single port may be used fortreating a single eye. In cases where the tissues around only the firsteye are treated, a single port may be utilized. Connector indicators 358may be included to provide a visual indicator (and/or auditoryindicator) to indicate to the user whether the first and/or second ports354 have heaters properly connected. A charging port 356 for connectingto a power supply for charging the controller 350 may also beincorporated into the housing 352. Ports for heater assemblies 354 onthe controller may be oriented relative to the charging port 356 suchthat charging is not possible with any number of heaters connected tothe controller.

A power button 360 may be provided to allow the user to activate thecontroller 350 on/off and a power indicator 362 may also be provided toshow the power level of controller 350. In addition to the powerindicator 362, a temperature controller 364 may also be provided toallow for the user to adjust the temperature of the strip assembliesduring treatment, e.g., by pressing the “+” or “−” as appropriate.Additionally, a timer 366 may also be provided to give feedback like avisual (and/or auditory) countdown of the treatment time. For instance,when a 12 minute timer has been initiated, each indicator bar of thetimer 366 may pulse for 1 min then turn off until the entire 12 minutetreatment time has elapsed.

As shown in the perspective views of FIGS. 41A and 41B, the controller350 may provide a visual indication, as indicated by the connectorindicators 358, of when the first connector 370A for the first treatmentstrip assembly has been inserted into the first port 354A. and likewisewhen the second connector 370B for the second treatment strip assemblyhas been inserted into the second port 354B.

FIGS. 42A and 42B illustrate various perspective views of the controller350 with the housing 352 shown as transparent for clarity purposes toillustrate some of the internal components contained within the housing352. For instance, a first and second power source 380A, 380B, e.g.,rechargeable batteries, may be incorporated into the housing 352 forsupplying the power to respective first and second treatment assemblies.Additionally, a controller board 382 having a programmable processor mayalso be incorporated into the housing 352 for controlling the treatmentparameters as well as for controlling various safety features.

For instance, the controller board 382 and processor may be programmedinitiate a therapy session by applying power to the treatment stripassemblies (when connected to the controller 350) for a treatment timeof approximately 12 minutes (although this treatment time may be alteredas needed or desired). The applied voltage provided by the power source380A, 380B may be actuated by the controller board 382 to provide acurrent through the electrical traces of the heater strips to apply heatto the eyelids at a temperature of approximately 42.5° C. The controllerboard 382 may be programmed to heat the treatment strips to atherapeutic temperature within, e.g., 20 seconds, of initiating therapy(e.g., in a temperature controlled setting such as room temperature,20-26° C.).

The controller board 382 may be programmed to include a temperaturesensing feedback loop capable of maintaining a nominal temperature of42+/−1° C. and may be further programmed to provide a visual and/orauditory warning if the treatment strips drop below a thresholdtemperature, e.g., 39° C., at any time during treatment. The controllerboard 382 may also be programmed to prohibit the treatment strip surfacetemperatures from exceeding a maximum temperature for a predeterminedperiod of time, e.g., 48° C. for a cumulative period of time no greaterthan 5 seconds, during treatment. The controller may be programmed todiscern discrepancies in temperatures in any single treatment strip,which may indicate partial application of the strip on a patients face.Each strip may have multiple sensors to provide for accuracy regardingregional temperature differences along the strip and optionally todetect temperatures separate from the strips more accurately and rapidlyand to adjust accordingly.

If the patient determines that the treatment strip assemblies are toohot, the user may adjust the treatment temperature by adjusting thetemperature controller 364 or the treatment may be stopped by either 1)momentarily pressing the power button 360 on the controller 350, 2)turning off the controller 350 (e.g., holding the power button for 3-5seconds), 3) unplugging the treatment strip assemblies from thecontroller 350, or 4) removing the treatment strip assemblies from thepatient's eyelids. After the treatment has been completed or stopped,the treatment strip assemblies may be removed from the patient'seyelids, disconnected from the controller 350, and disposed of.

The power source 380A, 380B within the controller 350 may be sufficientfor at least five 12-minute heat treatment cycles and the controllerboard 382 may be programmed to prevent a treatment cycle from initiatingwhen recharging is required (e.g., less than 25% charge remaining in thepower source 380A, 3808).

Additionally, the controller board 382 may also be programmed toautomatically shut off power to the treatment strips when the one orboth connectors 370A, 370B are unplugged from their respective ports354A, 354B. A treatment session may be paused and the temperatureindicator 364 may change in status to provide an indication that atreatment strip is unplugged.

Additionally, the controller board 382 may be further programmed toprovide an automatic shutoff after a period of inactivity, e.g., 15second, outside of is heating cycle (no start/stop, plugging of heatersor charger, etc.).

The controller 350 may be rechargeable either via direct connection to apower supply through charging port 356. Alternatively, a separatecharging station 390 may be provided which provides a receiving cradle392 for holding the controller 350, as shown in the perspective view ofFIG. 43. The charging port 356 may be aligned with a charging portintegrated into the receiving cradle 392. In other variations, thecharging station 390 may be configured to wirelessly charge thecontroller 350, e.g., via inductive charging, so that the controller 350may be simply placed into proximity of the charging station 390 ratherthan being plugged into a charging connector.

In yet another alternative, the controller 350 may have a replaceablebattery pack or packs, which may be recharged external to the controller350, and exchanged by the user when one pack has been depleted.

With respect to the treatment strip assemblies, another variation isshown in the perspective view of FIG. 44 which illustrates heatingstrips 400A, 400B (which may be applied to the upper lid UL and lowerlid LL) which are coupled via respective connectors 402A, 402B (e.g.,flexible connectors to accommodate the positioning of the heating strips400A, 400B to the patient) to a common junction 404 coupling the heatingstrips 400A, 400B. The junction 404 may be connected to a coupler 410having a receiving port 412 which is sized to removably receive thejunction 404. The coupler 410 may be connected to a cable 414 (e.g.,which may be several feet in length to reach from patient's eyes to thecontroller 359 when located on the wrist) which is then coupled to theport 354A or 354B.

Because the treatment strip assemblies may be designed for single use,the treatment strips may be marked or otherwise electronically tagged(such as via junction 404 or some other indicator) to prevent theirre-use by the controller hoard 382 when previously used treatment stripsare connected to the controller 350. In one variation, the junction 404may incorporate a usage tracking mechanism 408 such as a memory chipthat may be programmed to have a “0” or “1” memory which may indicate tothe controller board 382 that the particular treatment strip assemblyhas previously been used, as shown in the detail perspective view ofFIG. 45A. In another variation, the usage tracking mechanism 408 maycomprise a sacrificial fuse located on the junction 404. A short burstof high energy may be delivered by the controller to the mechanism 408to blow the fuse. Then the energy for treatment may be lowered by thecontroller to deliver the proper temperature therapy. Optionally, oncethe treatment strip assembly has been used, the junction 404 may beremoved from receiving port 412 and another junction for a new treatmentstrip assembly may be inserted for another treatment or for anotherpatient.

In other variations, rather than having a wired connection, thetreatment strips may incorporate an antenna and transmitter and/orreceiver for communicating wirelessly with the controller board 382.

Each of the heating strips 400A, 400B may include one or more respectivesensors 406A, 406B, e.g., thermistors or thermocouples, which may becoupled to a common wire connector or separate wires and positioned uponthe strips to provide treatment feedback to the controller board 382 foreach eyelid strip, as also shown in FIG. 45A. Each of the heating strips400, 400B, for instance, may incorporate anywhere from 1-4 temperaturesensors on each strip, e.g., one sensor positioned on a first end, asecond sensor positioned on the middle, and a third sensor positioned ona second end of the strip. FIG. 45B shows a top view of the heatingstrips 400A, 400B illustrating how each strip may incorporate one ormore sensors. As shown, the first strip 400A may have a first sensor420A positioned near or at a first end such as a distal end of thestrip, a second sensor 420A′ positioned mid-way along the strip, and athird sensor 420A″ positioned near or at a second end such as theproximal end of the strip. Likewise with the second strip 400B, a firstsensor 420B may be positioned near or at a first end such as a distalend of the strip, a second sensor 4208′ may be positioned mid-way along,the strip, and a third sensor 420B′ may be positioned near or at asecond end such as the proximal end of the strip.

An additional temperature sensor may also be placed upon or in proximityto the patient body, e.g., near the patient's temple, upon an additionaltreatment strip and away from the treatment strips placed upon thepatient's eyelids to measure and monitor an ambient temperature wherethe patient is being treated. This separate ambient temperature data mayhelp to ensure that the treatment strips themselves are working properlyand delivering the targeted temperature therapy. Sensors may be used ina comparative mode to determine if any portion of the treatment strip isnot in contact with the patient or is malfunctioning.

In treating conditions such as meibomian gland dysfunction (MGD), whichis commonly associated with the evaporative form of dry eye syndrome(DES), the meibomian glands may be mechanically pressed or squeezed toexpress solidified meibum from the glands in order to help treat MGD.Forceps are typically used to apply pressure upon the meibomian glands.The forceps may be modified to create a pressure gradient upon themeibomian glands to direct meibum and any other meibomian glandsecretions towards the meibomian gland orifices. This pressure gradientmay be increased by the optional incorporation of one or more featuresalong the compression surfaces of the forceps. Additionally and/oralternatively, the forceps may be configured to also provide a thermaltreatment, e.g., to the eyelid surfaces to simultaneously melt, soften,or liquefy and express meibum to increase its therapeutic efficacy.

The forceps may be used after (or during) a heat treatment incombination with the heating strips as described herein. Alternatively,the forceps may be used to first apply a heat treatment to melt themeibum plugs contained within the glands and then the forceps may beused to mechanically express the liquefied meibum before itre-solidifies. In another alternative, the forceps may be used to applya thermal treatment and mechanical expression simultaneously toeffixtively express the Meibum. In treating the meibomian glands, theforceps may also be used to apply heat to other regions, e.g., innereyelids, outer eyelids, or both. However, when the heating strips areused to apply a heat treatment to a patient, the forceps used formechanically expressing the glands may be configured to separately heatthe glands and/or they may include any number of mechanical features, asdescribed herein, to facilitate mechanical expression.

Aside from treating MGD, the forceps may also be used to treat otherconditions such as acne, arthralgia, myalgia, hordeolum, styes,chalazion, abcesses, other dermatological conditions, etc. The forcepsmay also be used for dental applications such as curing adhesives,fillings, etc. Additionally, the forceps may be used for other medicalpurposes such as tissue ablation, maintaining hemostasis, etc., as wellas non-medical purposes such as welding-type applications.

One variation of the forceps is shown in the perspective view of FIG. 46which illustrates forceps 430 which has a first handle 432A and secondhandle 432B coupled at a proximal end and optionally positioned toextend in parallel such that a respective first bridge 436A and secondbridge 436B project and optionally curve relative to the handles 432A,4328 such that a first jaw or paddle 434A is aligned in apposition to asecond jaw or paddle 434B. The first paddle 434A and second paddle 434Bmay also be aligned such that a respective first inner surface 438A andsecond inner surface 438B are angled relative to one another to impart adirectional pressure gradient, e.g., in a direction perpendicular to thedirection of the force applied, upon the contacted tissue forfacilitating meibomian gland expression, as described in further detailbelow. Alternatively, the angled surfaces of the paddle may articulaterelative to one another, creating a progressive pinching motion orprogressive apposition of paddle surfaces from one paddle edge to theother. The first and second paddies 434A, 434B may be sized forpositioning in proximity to the eyes and directly upon the eyelids of apatient and the paddles 434A, 434B may also be spaced apart from oneanother to allow for the positioning of the tissue (e.g., eyelid tissuecontaining the meibomian glands) in-between. In other variations, thefirst and second handles 432A, 432B may be curved or arcuate providedthat the paddles 434A, 434B are spaced apart from one another.

The forceps 430 may be disposable after a single use or it may beconfigured to be fully reusable. Alternatively, it may be configured tobe partially disposable, e.g., having reusable handles 432A, 432B withremovably disposable first and second paddles 434A, 434B or otherportion. Hence, the forceps 430 may be fabricated in part or in wholefrom any number of various materials, e.g., polymers, metals,composites, ceramics, etc. One or both of the paddles may be suitablysized for application to various regions of the body but when configuredfor treating the meibomian glands, the paddles may have a height Hranging anywhere, e.g., between 1 mm to 20 mm with a length L ranginganywhere, e.g., between 1 mm to 50 mm. In one variation, one or bothpaddles may have a height H and length L of, e.g., respectively, 5 mm by25 mm.

Additionally, one or both paddles 434A, 434B may optionally incorporatean insulating or reflective layer 441 which may be used to protect thecontacted tissues as well as to increase the efficiency and efficacy ofa treatment therapy. The insulating or reflective layer 441 may beintegrated on a single or both inner snakes and they may also beconfigured to cover a partial surface or the entire surface of thepaddle, as needed or desired.

In treating the meibomian glands, one or both paddles 434A, 434B may beconfigured to heat up to a predetermined temperature range andoptionally for a predetermined period of time. In one variation, theforceps 430 may have heating strips or sleeves which may be attached orsecured or otherwise applied as separate elements onto their respectivepaddles. The perspective view of FIG. 47A shows one variation wherefirst heating assembly 442A and second heating assembly 442B may eachincorporate a respective first and second heating element 446A, 446B,e.g., resistive heating wire, upon or within a contact surface of eachheating assembly 442A, 442B. The heating assemblies 442A, 442B, in thisvariation, may each define a respective first and second receivingcavity or channel 444A, 444B, such as a sleeve, into which the first andsecond paddles 434A, 434B may be inserted or attached. The heatingelements 446A, 446B may be in electrical communication with a controllerand/or power supply 440 which may be integrated with the forceps 430(e.g., within or along one or both of the handles 432A, 432B) orotherwise externally connected or coupled with the heating elements446A, 446B.

The controller 440 may incorporate a processor which is programmable aswell as a power supply which is rechargeable or disposable, if desired.In yet other variations, the controller 440 may be configured as amobile device such as a computer, smartphone, tablet, etc. which maycommunicate wirelessly with the heating elements or other features ofthe forceps 430. Other forms of communication between the heatingelements and the controller or power supply 440 may also be utilized.Examples include various forms of wired or wireless communication suchas standard wireless protocols, infrared, radiofrequency, ultrasound,etc. Alternatively, chemically powered heating elements, such as thosethat rely on exposure of elemental iron to atmospheric oxygen, or otherexothermic reactions, can be coupled to the forceps 430. The controller440 may also be programmed to incorporate features such as auditory,visual, or haptic alerts which can provide an indication to the user orphysician of certain parameters, e.g., when a treatment temperature hasbeen reached, when a predetermined period of time has passed forsqueezing of the glands before the forceps are released, etc.Additionally and/or alternatively, the forceps may incorporate anoptional actuator 439 for automatically compressing and releasing thetissue between the forceps paddles while under control via thecontroller 440 (as shown below in FIGS. 47A-47B).

FIG. 47B shows a side view of another variation of a single handle 432Band paddle 434B (for clarity purposes only) where the heating element448 may be incorporated directly upon or within the paddle 434B. Theheating element 448 may be electrically coupled to the controller and/orpower supply 440 and may be attached to the paddle 434B through anynumber of securement mechanisms, e.g., adhesives, magnetic, clips,fasteners, etc. In either variation, the heating element may be used togenerate or remove energy from the contacted tissue region being treatedby the forceps 430 to create an isolated microenvironment where theenergy may be delivered for thermal therapy (or diagnosis) and toconfine the area under treatment so as to prevent or inhibit surroundingtissues from unnecessary treatment or damage.

Additionally and/or alternatively, the forceps 430 may also incorporatevarious other treatment features, e.g., fluid irrigation, blower orvacuum, etc., for enhancing the cooling or heating within the treatmentregion. Moreover, aside from resistive heating elements, other heatingmodalities may also be incorporated, e.g., infrared, ultrasound,vibrational energy. RF (single or di-pole), electromagnetic radiationsuch as ultraviolet light or x-rays, inductively transferred energy,thermal conduction, etc. Other mechanisms for beating the heatingelements may also be utilized, such as induction heating, chemicalmechanisms, fluid flow with a heater reservoir, etc.

In the event that an electromagnetic radiation is applied between thepaddles, an electrical field may be created between the paddles 434A,434B via electrodes or electrical grid positioned along or within thepaddles. The voltage applied may be relatively low level and used toheat the tissue between the paddles and/or for other treatments such asiontophoresis to facilitate the delivery of agents such as drugs intothe underlying tissue.

Additionally and/or alternatively, the treatment applied via theindividual paddles may also be configured in a number of differentcombinations. For instance, the first paddle 434A may be configured toapply a heat treatment while the second paddle 434B may be configured toapply a different energy modality such as vibrational energy, lightenergy, etc. or it may simply be used to apply the compressive forceagainst the first paddle 434A. Regardless, the energy modality for eachindividual paddle may be configured to vary from one another as sodesired and in any one of the combinations of different features asdescribed herein.

When the heating element 448 is incorporated directly into one or bothof the paddles, the heating element 448 may be positioned in a number ofdifferent configurations. FIGS. 48A and 48B show perspective and endviews of a single paddle 434A, in one example, where the heating element448 (illustrated in this example as a resistive heating wire or tracewound in an alternating manner) may be positioned upon or beneath theinner surface 438A which comes into contact with the tissue beingtreated. Another variation is shown in the perspective and end views ofFIGS. 49A and 49B which show the heating element 448 positioned withinthe interior of the paddle 434A such that the element 448 is positionedmid-way from the inner surface 438A. Yet another variation is shown inthe perspective and end views of FIGS. 50A and 50B which show theheating element 448 positioned upon or beneath an outer surface of thepaddle 434A such that the element 448 is positioned away from the innersurface 438A.

In applying the thermal therapy, the heating element 448 (in one or bothpaddles) may be heated to a temperature which is effective for meltingsolidified meibum, e.g., between 35° C. to 50° C. or preferably between38° C. to 43° C., or more preferably between 41° C. to 43° C. Moreover,the treatment times over which the heated forceps 430 may be applied tothe tissue region being treated may also be varied any, e.g., between 0to 30 min., or preferably between 5 to 15 min., or more preferablybetween 10 to 12 min, in treatments where the forceps may be locked andotherwise secured upon the patient. In other variations, the treatmenttime may vary, e.g., between 1 to 2 mins per eyelid, when the eyelidsare actively treated and monitored by the user or physician.

As described above, the respective first inner surface 438A and/orsecond inner surface 438B may be angled relative to one another toimpart a directional pressure gradient upon the contacted tissue forfacilitating meibomian gland expression when compressed between thepaddles 434A, 434B. An example is illustrated in the handle 432A andpaddle 434A of FIG. 51A single handle and paddle is shown for claritypurposes only). When the paddles 434A, 434B are urged towards oneanother, one or both inner surfaces 438A, 438B may be angled relative toone another, as shown in the end view of FIG. 51B, such that compressionof the tissue between the paddles 434A, 434B creates the directionalpressure gradient 450 which may urge the compressed meibum away from thepaddles 434A, 434B. Alternatively, the angled paddles may articulatewith added pressure, allowing a progressive pinching motion to beapplied to the glands during or after heating.

FIG. 52A illustrates an end view of one variation where both the firstpaddle 434A and second paddle 434B may each be angled relative to oneanother and relative to a centerline CL defined by the forceps such thatinner surfaces 438A, 438B may define an angle α which creates thedirectional pressure gradient 450. FIG. 52B illustrates an end view ofanother variation where, e.g., the first paddle 434A may have its innersurface 438A aligned with the centerline CL and the second paddle 434Bmay have its inner surface 438B angled relative to the inner surface438A and centerline CL to form an angle β. Either angle α or β may rangeanywhere, e.g., between 0° to 30°, or preferably between 5° to 15°, ormore preferably will be about 5 ⁰. Regardless of the angle at which thepaddles 434A, 434B are aligned (or misaligned), the forceps are intendedto be combined with any of the heating element variations describedherein. The angulation of the paddles may be static, or vary duringapplication of pressure such that the paddles may become parallel atsome maximum force applied to the forceps.

Because the forceps 430 are designed to compress the tissue between thepaddles, the forceps may be configured to have locking or non-lockinghandles. Additionally, the handles may be manually or automaticallyactuated to apply the compression forces such that the paddles may becompressed in a sustained continuous manner or in an intermittent orpulsed manner. In the event that the forceps are automaticallycompressed either in a sustained, intermittent, or pulsed manner, thecontroller 440 may be programmed to apply the compression in the desiredmanner, at the desired temperature, and for the desired period of time.The forceps as intended for manual use may be constructed in a manner,or with materials, that limit the maximum amount of compression force onthe glands to limit trauma to the patient, this includes but is notlimited to travel stops, flexural beams that may sustain known limitedloads.

FIG. 53A shows a perspective view of forceps which may incorporateanother optional feature upon the paddles 460A, 460B. One or both of theinner surfaces may define any number (e.g., one or more) of featureswhich facilitate the creation of the directional pressure gradient 450described above. The variation of FIG. 53A illustrates one feature whereone or both of the paddle surfaces may define indentations or grooves462 which are aligned in parallel with the directional pressure gradient450, e.g., in the direction of the paddle height. The grooves 462 shownmay extend partially within the inner surface and may extend at leastpartially over the inner surface from the upper edge shown. FIG. 53Bshows another variation where grooves 466 may similarly extend over theinner surface of paddle 464 in a parallel manner but with alternatinggrooves having different lengths to create a differential pressuregradient. FIG. 53C shows a perspective view of another variation wherethe inner surface of paddle 468 may define bumps or projections 470. Theprojections 470 may be uniform in size and dimension and may also beuniformly positioned, over the inner surface. Alternatively, as shown,the projections 470 may range in size from relatively larger to smallerthe closer the projections 470 are located to the upper edge of thepaddle 468. In yet another variation shown in the perspective view ofFIG. 53D, the paddle 472 may define grooves or pits or depressions 474which extend into the inner surface rather than projecting outwardly.Similarly, the pits or depressions 474 may be uniform in size as well asuniform in positioning relative to one another. Alternatively, as shown,the pits or depressions 474 may range in size from relatively larger tosmaller the close the pits or depressions 474 are located to the upperedge of the paddle 472. FIG. 53E shows yet another variation wherepaddle 476 may define pits or depressions 478 which progressivelyincrease in size from the lower edge to the upper edge of the paddle476. Such a design may further facilitate the creation of the pressuregradient in facilitating treatment of the meibomian glands. The featuresmay be formed of a solid construct (single component) or of multiplecomponents that allow relative movement of the features and or permitmotion of the feature across the membranes, (e.g., ball bearings formingbumps, rollers forming projections/groves). Alternatively, thegrooves/projections 462, 466, 470, 474 may be capable of translationacross the face of the paddle, in parallel or at some angle to long-axisof the paddle, creating a dynamic pressure gradient.

With any of these features described, they may be utilized in any numberof combinations either on the inner surface of a single paddle or bothpaddles. For example, the grooves 466 of FIG. 53A or 53B may be definedalong both paddles while in other variations, the projections 470 ofFIG. 53C may be defined on a first paddle while the pits or depressions474 of FIG. 53D may be defined on the second paddle such that the twoapposed inner surfaces create interlocking contact surfaces.Additionally, features such as the grooves may be configured to mirrorthe anatomy of the meibomian glands to further facilitate engagementwith the tissue and expression of the meibum. Moreover, any of thesesurface features are intended to be utilized in any number ofcombinations with any of the angled (or non-angled) paddle variations aswell as with any of the heated paddle variations in any number ofconfigurations.

Aside from surface features on the paddle inner surface, variations inthe paddle shape may also be utilized in any number of combinations,FIG. 54A shows a perspective view of one variation where the forceps 480may utilize a first paddle 482A and a second paddle 482B which areconfigured to have a curved or arcuate shape. In yet another variation,shown in the perspective view of FIG. 54B, paddles 484A, 484B may beshaped to have a rectangular configuration while FIG. 54C shows anotherconfiguration where the paddle 486 may extend along its heightequidistant in either direction from bridge 436A to present an enlargedinner surface. FIG. 54D also shows another configuration of a paddle 488also having a rectangular shape but where the height extends away fromthe bridge 436A in an “upward” direction as opposed to the heightextending away from the bridge 436A in a “downward” direction as shownin FIG. 54B.

FIG. 55A shows yet another variation in forceps 490 where first andsecond paddles 492A, 492B are configured into a square configuration, asshown in the detail view of FIG. 55B, rather than a rectangular shape.FIG. 55C shows yet another variation where the first and second paddles494A, 494B may be shaped into an elongated configuration. FIG. 55D showsanother variation where the first and second paddles 496A, 496B may beshaped to extend from the bridge as a cylindrical shape optionally havea number of projections extending from the paddles. FIG. 55E shows yetanother variation where the first paddle 498A may be shaped into arectangular or square configuration while the second paddle 498B may beconfigured into another shape, such as a T-shaped configuration.Additionally, other paddle types may also be used with any of thevariations described herein, for example, where the paddles may bereplaced with a phaco-needle type forceps.

In any of these varying paddle configurations, any of these shapes maybe utilized in a uniform complementary configuration or in any othershape combinations when a first paddle has a first configuration and asecond paddle has a second configuration different from the firstconfiguration. Moreover, any of the paddle configurations are intendedto be utilized in any number of combinations with any of the paddleconfigurations have surface features and/or in combination with any ofthe paddles having varying angled configurations and/or in combinationwith any of the heating element configurations.

In yet another variation, FIG. 56 shows a perspective view of anothervariation where the forceps 480 may incorporate heating elements 500A,500B along the respective paddles 482A, 482B along with one or moreoptional sensors positioned along the heating elements or paddles. Inthe variation, a first sensor 502 may be positioned along, a distalportion of the paddle, a second sensor 504 may be positioned mid-wayalong the paddle, and a third sensor 506 may be positioned along aproximal portion of the paddle. Although three sensors are shown in thisexample, a fewer number of sensors or a greater number of sensors may beutilized at different locations. The sensors in this variation maycomprise temperature sensors, such as thermocouples or thermistors,while other sensor types (e.g., chemical sensors, oxygen, blood flow,force, pressure, impedance, etc.) may also be utilized in othervariations. Such sensors may be incorporated along the paddles alone orin any number of combinations with any of the variations describedherein.

Additionally, any of the paddles may also incorporate any number ofdrugs (e.g., anesthetics, antibacterial agents, etc.) upon the paddlesurfaces or through delivery mechanisms which may be infused or placedupon the tissue when contacted by the forceps.

Another variation is shown in the perspective view of FIG. 57 whichillustrates paddles 434A, 434B optionally incorporating collectionreservoirs 510A, 510B which may define one or more specimen collectionvias or ports such that the reservoirs are in fluid communication withthe contacted tissue positioned between the paddle inner surfaces.Although two reservoirs 510A, 510B are shown, a single reservoir may beincorporated. The reservoirs 510A, 510B may be used to collect any glandexpression for testing and analysis in either real time or after atreatment procedure has been completed. The pores or texture on theinner surfaces of the paddles may be designed such that expressed fluidsmaintain their position relative to individual glands that producedfluids, which may then be used for evaluation of disease progression.

While any of the forceps or forceps combinations described herein may bepackaged and distributed individually, they may also be packaged intokits 520, as shown in FIG. 58, to include not only the forceps 430 butalso various combinations of additional devices or treatments. In oneexample, a pharmaceutical treatment 522 (e.g., eyedrops, ointments,medications, etc.) may be included as well as optional heating strips524 which may be applied to the skin surface of the patient's eyelids(or in proximity to the eyelids) for heating and/or pre-heating themeibomian glands prior to or during gland expression with the forceps430. Such a kit 520 may provide a complete treatment solution. Moreover,while pharmaceutical treatment 522 and optional heating strips 524 areshown included in the kit 520 along with the forceps 430, anycombination of these may be included within the kit 520 as well asvarious other treatments or devices.

Another example of a kit 540 is shown in FIG. 59A which illustrates oneor more heating strips 524 provided in combination with forceps 542. Inthis variation, the forceps 542 may be configured with paddles 464 whichdefine grooves 466 extending over the inner surface(s) between the lowerand upper edges of one or both paddles 464 to facilitate mechanicalexpression after (or before) the heat treatment. Optionally, the heatingstrips 524 may be single-use and disposable, if so desired.

FIG. 59B shows yet another example of a kit which includes the one ormore heating strips 524 and forceps 542, as described above, but whichalso optionally includes a controller 350 for controlling the heattreatment of the one or more heating strips 524. The controller 350 maybe a re-usable unit while the heating strips 524 and/or forceps 542 maybe optionally configured as single-use and disposable, if so desired.

As discussed, any of the forceps variations and combinations describedherein may be used alone for treating a patient or they may be used incombination with any of the treatment apparatus and methods described infurther detail in U.S. patent application Ser. No. 13/645,985 filed Oct.5, 2012 and U.S. patent application Ser. No. 13/343,407 filed Jan. 4,2012, which are each incorporated herein by reference in its entiretyand for any purpose herein, particularly for treatment of MGD and dryeye syndrome. These references also describe the heating strips 524 infurther detail for optional inclusion with any of the kits.

The applications of the devices and methods discussed above are notlimited to the treatment of dry eye syndrome but may include any numberof further treatment applications. Moreover, such devices and methodsmay be applied to other treatment sites within the body where acute orchronic inflammation causes a disease or condition. The treatment stripscan be accordingly custom-designed to follow the path of the underlying,physiology, e.g. custom designed and contoured cooling or heating,treatment strips to treat the sinuses and acute or chronic sinusitis,respectively, rhinitis and allergic rhinitis, joint aches andinflammation, arthritis, muscle aches, back pain, headaches, wounds,sports injuries, etc., Modification of the above-described assembliesand methods for carrying out the invention, combinations betweendifferent variations as practicable, and variations of aspects of theinvention that are obvious to those of skill in the art are intended tobe within the scope of the claims.

What is claimed is:
 1. A treatment system, comprising: one or morestrips configured to adhere to an underlying region of skin in proximityto one or both eyes of a subject such that the one or more strips allowfor the subject to blink naturally with minimal, or no restriction fromthe one or more strips; and a controller in communication with the oneor more strips, wherein the controller is programmable to monitor andinduce a temperature in the one or more strips to provide a therapy,wherein, the controller is further programmable to maintain a set pointabove a threshold temperature and below a maximum temperature over apredetermined treatment period, wherein the one or more strips areconfigured to emit thermal energy to the underlying region of skin, andwherein the one or more strips are shaped to follow a location of one ormore meibomian glands contained within the underlying, region of skin.2. The system of claim 1 herein the controller comprises a temperaturecontroller.
 3. The system of claim 1 wherein the threshold temperatureis 39° C.
 4. The system of claim 3 wherein the maximum temperature is48° C.
 5. The system of claim 4 wherein the treatment period is 12minutes.
 6. The system of claim 1 wherein the controller is programmedto provide a treatment temperature of 42° C.+/−1° C.
 7. The system ofclaim 1 wherein the controller is programmed to maintain a treatmenttherapy at the temperature of 48° C. for a cumulative period of time nogreater than 5 seconds.
 8. The system of claim 1 further comprising apower source having a charge sufficient for at least five 12-minute heattreatment cycles.
 9. The system of claim 8 wherein the controller isprogrammed to prohibit a treatment therapy when the power source isbelow a threshold value.
 10. The system of claim 1 wherein thecontroller is programmed to automatically shut power off from the one ormore strips when a connector coupled to the one or more strips isdisconnected from the controller.
 11. The system of claim 1 wherein thecontroller is programmed to provide an automatic shutoff after a periodof inactivity.
 12. The system of claim 1 wherein the one or more stripscomprise a contact surface for placement against the region of skin. 13.The system of claim 1 wherein the one more strips comprise a heatinglayer in thermal communication with the region of skin.
 14. The systemof claim 1 wherein the one or more strips each have a first curved orarcuate periphery which is shaped to extend and follow a border of theone or more meibomian glands and a second curved or arcuate peripherywhich is shaped to extend and follow a free margin of an upper or lowereyelid.
 15. The system of claim 1 wherein the controller is programmedto provide an auditory, visual, or haptic indicator for communicatingwith the user.
 16. The system of claim 1 further comprising a usagetracking mechanism in communication with the controller.
 17. The systemof claim 1 wherein the controller is programmed to detect a partialapplication of the one or more strips on the region of skin.
 18. Thesystem of claim 1 further comprising a forceps for mechanicallyexpressing the one or more meibomian glands.
 19. The system of claim 18wherein the forceps comprise: a first handle and a second handle coupledto one another near or at respective proximal ends; a first paddlecoupled to the first handle and defining a first inner surface; a secondpaddle coupled to the second handle and defining a second inner surfacewhich is positioned in apposition to the first inner surface, whereinthe first inner surface and/or the second inner surface define one ormore grooves such that a directional pressure gradient is createdbetween the first and second inner surfaces when the surfaces areapproximated towards one another.
 20. The system of claim 19 furthercomprising at least one beating element integrated or secured upon atleast one of the first paddle and second paddle.
 21. The system of claim20 wherein the at least one heating element is positioned upon the firstinner surface and/or second inner surface.
 22. The system of claim 20wherein the at least one heating element is positioned upon an outersurface of the first paddle and/or second paddle.
 23. The system ofclaim 19 wherein the first inner surface and second inner surface forman angle of between 0° to 30°.
 24. The system of claim 19 wherein thefirst paddle and/or second paddle are configured in a rectangular shape.25. The system of claim 19 wherein the first paddle and/or second paddleare configured in a curved or arcuate shape.
 26. The system of claim 19further comprising one or more sensors positioned upon the first paddleand/or second paddle.
 27. The system of claim 19 wherein the firstpaddle and/or second paddle further comprise a reservoir in fluidcommunication for collecting a fluid specimen expressed from tissue. 28.A treatment system, comprising: one or more strips configured to adhereto an underlying region of skin in proximity to one or both eyes of asubject such that the one or more strips allow for the subject to blinknaturally with minimal, or no restriction from the one or more strips,wherein the one or more strips are configured to emit thermal energy tothe underlying region of skin, and wherein the one or more strips areshaped to follow a location of one or more meibomian glands containedwithin the underlying region of skin; and a forceps for mechanicallyexpressing the one or more meibomian glands.
 29. The system of claim 28wherein the forceps comprise: a first handle and a second handle coupledto one another near or at respective proximal ends; a first paddlecoupled to the first handle and defining a first inner surface; a secondpaddle coupled to the second handle and defining a second inner surfacewhich is positioned in apposition to the first inner surface, whereinthe first inner surface and/or the second inner surface define one ormore grooves such that a directional pressure gradient is createdbetween the first and second inner surfaces when the surfaces areapproximated towards one another.
 30. The system of claim 28 furthercomprising: a controller in communication with the one or more strips,wherein the controller is programmable to monitor and induce atemperature in the one or more strips to provide a therapy, wherein, thecontroller is further programmable to maintain a set point above athreshold temperature and below a maximum temperature over apredetermined treatment period.
 31. The system of claim 30 wherein thecontroller comprises a temperature controller.
 32. The system of claim30 wherein the threshold temperature is 39° C.
 33. The system of claim32 wherein the maximum temperature is 48° C.
 34. The system of claim 33wherein the treatment period is 12 minutes.
 35. The system of claim 30wherein the controller is programmed to provide a treatment temperatureof 42° C.+/−1° C.
 36. The system of claim 28 wherein the one or morestrips each have a first curved or arcuate periphery which is shaped toextend and follow a border of the one or more meibomian glands and asecond curved or arcuate periphery which is shaped to extend and followa free margin of an upper or lower eyelid.
 37. A method of treating asubject, comprising: adhering an upper strip to an upper eyelid of asubject such that the upper strip has a flexibility sufficient toaccommodate movement of the upper eyelid to allow for the subject toblink naturally without restriction from the upper strip while coveringone or more meibomian glands contained within the upper eyelid with theupper strip, wherein the upper strip has a first curved or arcuateperiphery which is shaped to extend and follow a border of the one ormore meibomian glands contained within the upper eyelid and a secondcurved or arcuate periphery which is shaped to extend and follow a freemargin of the upper eyelid; initiating a treatment with the upper stripvia a controller transmitting electrical energy to the upper strip via aconnecting cable; emitting thermal energy from the upper strip to theupper eyelid; and expressing the one or more meibomian glands.
 38. Themethod of claim 37 further comprising adhering a lower strip to a lowereyelid of the subject such that one or more meibomian glands containedwithin the lower eyelid are covered by the lower strip.
 39. The methodof claim 38 wherein the lower strip has a first curved or arcuateperiphery which is shaped to extend and follow a border of the one ormore meibomian glands contained within the lower eyelid and a secondcurved or arcuate periphery which is shaped to extend and follow a freemargin of the lower eyelid.
 40. The method of claim 38 wherein the upperstrip and lower strip are electrically coupled to one another.
 41. Themethod of claim 17 wherein emitting thermal energy comprises applyingthermal energy from a heating layer in the upper strip.
 42. The methodof claim 37 wherein initiating comprises programming the upper strip viaa controller attached to the upper strip.
 43. The method of claim 37wherein the method of treating comprises treating one or more conditionsselected from the group consisting of dry eye, evaporative dry eye, andMeibomian gland dysfunction.
 44. The method of claim 37 wherein themethod of treating comprises treating to improve one or more conditionsselected from the group consisting of an ocular surface, tear quality,lipid layer of tears, and tear break up time.
 45. The method of claim 37wherein the method of treating comprises treating to reduce Meibomiangland inflammation or ocular surface inflammation.
 46. The method ofclaim 37 further comprising monitoring, a temperature of the upper stripvia one or more temperature sensors incorporated into the upper stop.47. The method of claim 37 wherein emitting thermal energy comprisesheating the upper strip for at least 10 minutes or more.
 48. The methodof claim 37 wherein emitting thermal energy comprises heating the upperstrip for up to 15 minutes.
 49. The method of claim 37 whereinexpressing comprises expressing the one or more meibomian glands via aforceps.
 50. The method of claim 49 further comprising: positioning atissue region having the one or more obstructed meibomian glands betweena first paddle having a first inner surface and a second paddle having asecond inner surface, wherein the first inner surface and second innersurface define one or more grooves; and urging the first paddle andsecond paddle towards one another such that the tissue region iscompressed between the first inner surface and second inner surface anda directional pressure gradient is created within the tissue region, andwherein meibum is expelled from the one or more obstructed meibomianglands.
 51. The method of claim 50 further comprising maintaining thefirst paddle and/or second paddle within a predetermined temperaturerange while contacting the tissue region.
 52. The method of claim 50wherein the first inner surface and second inner surface are aligned atan angle of between 0° to 30°.
 53. The method of claim 37 furthercomprising collecting the meibum excreted from the one or moreobstructed meibomian glands.